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The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination with pembrolizumab.
This study also evaluated other measures of anticancer activity of ASP7517 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
This study consisted of arms receiving ASP7517 monotherapy and arms receiving ASP7517 and pembrolizumab combination therapy in Phase 1 (dose escalation cohort) and Phase 2 (dose expansion cohort). Phase 2 monotherapy and combination dose expansion cohorts were opened after the phase 1 escalation cohort was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 cells/dose) | Experimental | Participants received one dose of ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) by intravenous (IV) infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following first 2 cycles, participants not meeting treatment discontinuation criteria and receiving clinical benefit (defined:radiological response/SD/reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and those not clinically stable or clinical progression was confirmed by investigator and followed up to 48 weeks until iCPD per independent central review, initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
|
| Phase 1: Monotherapy dose escalation (ASP7517 1x10^8 cells/dose) | Experimental | Participants received one dose of ASP7517 1x10^8 cells/dose by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following first 2 cycles, participants not meeting treatment discontinuation criteria and receiving clinical benefit (defined as radiological response/ SD, or reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and those not clinically stable or clinical progression was confirmed by the investigator and followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7517 | Drug | Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | From first dose up to 30 days after last dose (maximum treatment duration: approximately 534[504+30] days) |
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Combination Therapy | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | From first dose up to 30 days after last dose (maximum treatment duration: approximately 847[817+30] days) |
| Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment | ORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. CR was complete response based on RECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. ORR assessment included:
|
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Inclusion Criteria:
Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy that is confirmed by available pathology records or current biopsy. Participant must also have received all standard therapies (unless the therapy is contraindicated or intolerable) appropriate to provide clinical benefit for his/her specific tumor type. However, participants with metastatic melanoma who have not received checkpoint inhibitors [CPIs] (i.e., CPIs naive) may enroll in the Phase 2 Combination Therapy Arm Dose Expansion Cohort to receive CPI: Pembrolizumab.
Participant must be diagnosed with solid tumor known to express WT1 antigen such as, but not limited to melanoma, ovarian cancer or Colorectal Cancer (CRC).
Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides, if available, prior to study treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of IP administration. A participant with BRAF gene, epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation positive non-small cell lung carcinoma is allowed to remain on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or anaplastic lymphoma kinase (ALK) or BRAF inhibitor therapy until 4 days prior to the start of Investigational Product (IP) administration.
Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to IP administration.
Participant's Adverse Events (AEs) (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of IP.
Participant has adequate organ function prior to start of IP. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.
A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
Female participant must agree not to breastfeed starting at screening and throughout the IP and for 180 days after the final IP administration.
Female participant must not donate ova starting at screening and throughout the IP and for 180 days after the final IP administration.
A male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for at least 180 days after the final IP administration.
Male participant must not donate sperm during the treatment period and for 180 days after the final IP administration.
Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 180 days after the final IP administration.
Participant agrees not to participate in another interventional study while receiving IP.
Additional Inclusion Criteria for Participants in the Expansion Cohorts:
Participant meets one of the following:
Participant has at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Participant consents to provide a tumor specimen in a tissue block or unstained serial slides obtained within 56 days prior to first dose of IP. If a recent tissue sample cannot be provided due to medical or safety concerns, enrollment into the study must be discussed with the medical monitor.
Participant consents to undergoing a tumor biopsy (core tissue biopsy or excision) during the treatment period as indicated in the schedule of assessments if predose biopsy is available and if medically feasible.
Exclusion Criteria:
Additional Exclusion Criteria for Participants in Combination Expansion Cohorts:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| University of Chicago |
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| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website. | View source |
| Link to plain language summary of the study on the Trial Results Summaries website. | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. No combination therapy dose expansion arm was enrolled.
Participants aged ≥ 18 years diagnosed with a locally-advanced (unresectable) or metastatic solid tumor known to express Wilms' tumor protein 1 (WT1) antigen were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1:Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) | Participants received one dose of ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) by intravenous (IV) infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or stable disease [SD], or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participant who achieved confirmed complete response (CR) did not continue with ASP7517, and any participants who achieved partial response (PR) or SD received an additional 2 doses. Participants entered an Observation Period except those with "immune" confirmed progressive disease (iCPD), unconfirmed disease progression disease (iUPD) (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the end of treatment (EOT) visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 Dose Escalation (Up to 817 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2022 | Jun 10, 2025 |
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| Phase 2:Monotherapy dose expansion (ASP7517 1x10^8 cells/dose) | Experimental | Participants received ASP7517 1x10^8 cells/dose by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants not meeting discontinuation criteria and were receiving clinical benefit (defined as radiological response/SD, or reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and who were not clinically stable or clinical progression was confirmed by the investigator and followed up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
|
| Phase1:Combination Therapy dose Escalation (ASP7517 1x10^7 cells/dose) and Pembrolizumab | Experimental | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4-6 mL/min) (1 Cycle = 28 days) with 400 mg pembrolizumab infusion (over 30 min) for up to 4 doses every 6 weeks. After 2 cycles, those not meeting discontinuation criteria and receiving clinical benefit continued ASP7517 and pembrolizumab. Participants with confirmed CR within 4 cycles did not receive ASP7517 at cycles 5-6; those with PR/SD after 4 doses received 2 more ASP7517 doses with pembrolizumab. After Treatment Period, all except those with iCPD, iUPD, or clinical progression entered Observation Period and continued pembrolizumab alone (up to 17 doses) to monitor response up to 96 weeks until iCPD, new therapy, or discontinuation criteria. After EOT visit, participants completed Safety follow-up at 30, 60, and 90 days. |
|
| Phase 1:Combination Therapy dose Escalation (ASP7517 1x10^8cells/dose) and Pembrolizumab | Experimental | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4-6 mL/min) (1 Cycle = 28 days) with 400 mg pembrolizumab infusion (over 30 min) for up to 4 doses every 6 weeks. After 2 cycles, those not meeting discontinuation criteria and receiving clinical benefit continued ASP7517 and pembrolizumab. Participants with confirmed CR within 4 cycles did not receive ASP7517 at cycles 5-6; those with PR/SD after 4 doses received 2 more ASP7517 doses with pembrolizumab. After Treatment Period, all except those with iCPD, iUPD, or clinical progression entered Observation Period and continued pembrolizumab alone (up to 17 doses) to monitor response up to 96 weeks until iCPD, new therapy, or discontinuation criteria. After EOT visit, participants completed Safety follow-up at 30, 60, and 90 days. |
|
| Pembrolizumab | Drug | Intravenous (IV) |
|
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. |
| At C1D1 |
| Number of Participants With ECOG Performance Status at C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C1D2 |
| Number of Participants With ECOG Performance Status at C1D4 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C1D4 |
| Number of Participants With ECOG Performance Status at C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C1D8 |
| Number of Participants With ECOG Performance Status at C1D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C1D15 |
| Number of Participants With ECOG Performance Status at C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C2D1 |
| Number of Participants With ECOG Performance Status at C2D4 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C2D4 |
| Number of Participants With ECOG Performance Status at C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C2D8 |
| Number of Participants With ECOG Performance Status at C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C2D15 |
| Number of Participants With ECOG Performance Status at C3D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C3D1 |
| Number of Participants With ECOG Performance Status at C3D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C3D8 |
| Number of Participants With ECOG Performance Status at C3D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C3D15 |
| Number of Participants With ECOG Performance Status at C4D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C4D1 |
| Number of Participants With ECOG Performance Status at C4D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C4D8 |
| Number of Participants With ECOG Performance Status at C4D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C4D15 |
| Number of Participants With ECOG Performance Status at C5D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C5D1 |
| Number of Participants With ECOG Performance Status at C5D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C5D8 |
| Number of Participants With ECOG Performance Status at C5D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C5D15 |
| Number of Participants With ECOG Performance Status at C6D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C6D1 |
| Number of Participants With ECOG Performance Status at C6D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C6D8 |
| Number of Participants With ECOG Performance Status at C6D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At C6D15 |
| Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose. | At EOT (Approximately 511 [504 +7] days) |
| Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy. | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose. | At EOT (Approximately 824 [817 +7] days) |
| Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 30 days safety Follow Up (Approximately 541 [511+30] days) |
| Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 30 days safety Follow Up (Approximately 854 [824+30 ] days) |
| Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 60 days safety Follow Up (Approximately 571 [511+60] days) |
| Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 60 days safety Follow Up (Approximately 884 [824+60] days) |
| Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 90 days safety follow up (Approximately 601 [511+90] days) |
| Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | At 90 days safety follow up (Approximately 914 [824+90] days) |
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT: any event occurring within 28 days of first dose on C1D1 and graded as: *Non-hematologic AEs >= grade 3 and not resolving to <= grade 2 within 72 hours. *Confirmed Hy's law case. *Infusion-related reactions requiring infusion discontinuation, prolonged delay (> 2 weeks) in initiating C2 due to treatment-related toxicity. *Any treatment-related toxicity causing discontinuation in C1. *Grade >= 3 thrombocytopenia/bleeding requiring transfusion/hospitalization, grade >= 3 anemia requiring transfusion, grade 3 febrile neutropenia with/without infection and grade 5 treatment-related toxicity, grade >= 2 pneumonitis, grade >= 2 encephalopathy, meningitis or motor/sensory neuropathy. *Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) in participants without liver metastases, AST/ALT > 8×ULN in participants with liver metastases, total bilirubin > 3×ULN (grade >= 3). *Guillain-Barré syndrome/myasthenic syndrome/myasthenia gravis. | From C1D1 up to C1D28 |
| Objective Response Rate (iORR) Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator Assessment | iORR was defined as the percentage of participants for each dose level whose best overall response was rated as confirmed iCR or iPR per iRECIST by independent central review. iCR was complete response based on iRECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iORR assessments included:
| From first dose up to 954 days |
| From first dose up to 954 days |
| Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment | iDCR: Percentage of participants for each dose level whose best overall response is rated as confirmed iCR, iPR or iSD per iRECIST. iCR: Complete response based on iRECIST, defined as disappearance of all target/non target lesions and pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR: Partial response based on iRECIST, defined as at least 30% decrease in the sum of diameters of target lesions, with reference to the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: Defined as at least 20% increase in the sum of diameters of target lesions, with reference to the smallest sum of diameters recorded since the treatment started. For confirmed response for iCR/iPR, scan had to be done 4 weeks after iPR/iCR was first observed. Participants who had iCR/iPR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response. | From first dose up to 954 days |
| Disease Control Rate (DCR) Per RECIST v1.1 by Investigator Assessment | DCR: Percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1. CR: Complete response based on RECIST and defined as disappearance of all target/non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR: Partial response based on RECIST and defined as at least a 30% decrease in the sum of diameters of target lesions, with reference to, the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, with reference to, the smallest sum of diameters recorded since treatment started. For confirmed response for CR/PR, scan had to be done 4 weeks after PR/CR was first observed. Participants who had CR/PR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response. | From first dose up to 954 days |
| Progression-Free Survival Per iRECIST (iPFS) Using Investigator Assessment | iPFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST by independent central review and investigator assessment, whichever occurs first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints. | From first dose until death from any cause or radiographic disease progression (up to 954 days) |
| Progression-Free Survival Per RECIST (PFS) Using Investigator Assessment | PFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST by independent central review and investigator assessment, whichever occurred first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints. | From first dose until death from any cause or radiographic disease progression (up to 954 days) |
| Overall Survival (OS) | OS was defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1). Kaplan Meier estimate was used for analysis of time-to-event endpoints. | From first dose until death from any cause (up to 954 days) |
| Duration of Response Per iRECIST (iDOR) | iDOR was defined as the time from the date of the first response iCR/iPR (whichever was first recorded) to the date of radiographical progression or date of censoring. iCR was complete response based on iRECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | From first response up to the date of radiographical progression (up to 954 days) |
| Duration of Response (DOR) Per RECIST v1.1 | DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1, separately for independent central review and for investigator assessment. CR was complete response based on RECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | From first response up to the date of radiographical progression (up to 954 days) |
| Chicago |
| Illinois |
| 60603 |
| United States |
| University of Iowa Hospitals | Iowa City | Iowa | 52242 | United States |
| UPCI Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| FG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| FG002 | Phase 2:Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| FG003 | Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by the investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review/local review, entered the Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| FG004 | Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 Dose Expansion (Up to 504 Days) |
|
|
Safety analysis set (SAF) consisted of all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) | Participants received one dose of ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| BG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| BG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| BG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| BG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Only participants with ECOG grades were reported. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | SAF | Posted | Number | Participants | From first dose up to 30 days after last dose (maximum treatment duration: approximately 534[504+30] days) |
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| Primary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Combination Therapy | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. | SAF | Posted | Number | Participants | From first dose up to 30 days after last dose (maximum treatment duration: approximately 847[817+30] days) |
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| Primary | Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF | Posted | Number | Participants | At C1D1 |
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| Primary | Number of Participants With ECOG Performance Status at C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. As per protocol no participants were planned to be enrolled in C1D2 for monotherapy dose expansion therefore, no participants were included in this arm. | Posted | Number | Participants | At C1D2 |
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| Primary | Number of Participants With ECOG Performance Status at C1D4 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF | Posted | Number | Participants | At C1D4 |
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| Primary | Number of Participants With ECOG Performance Status at C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF | Posted | Number | Participants | At C1D8 |
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| Primary | Number of Participants With ECOG Performance Status at C1D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF | Posted | Number | Participants | At C1D15 |
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| Primary | Number of Participants With ECOG Performance Status at C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At C2D1 |
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| Primary | Number of Participants With ECOG Performance Status at C2D4 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At C2D4 |
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| Primary | Number of Participants With ECOG Performance Status at C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At C2D8 |
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| Primary | Number of Participants With ECOG Performance Status at C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At C2D15 |
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| Primary | Number of Participants With ECOG Performance Status at C3D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D1 therefore, the number of participants is 0. | Posted | Number | Participants | At C3D1 |
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| Primary | Number of Participants With ECOG Performance Status at C3D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D8 therefore, the number of participants is 0. | Posted | Number | Participants | At C3D8 |
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| Primary | Number of Participants With ECOG Performance Status at C3D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D15 therefore, the number of participants is 0. | Posted | Number | Participants | At C3D15 |
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| Primary | Number of Participants With ECOG Performance Status at C4D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C4D1 therefore, the number of participants is 0. | Posted | Number | Participants | At C4D1 |
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| Primary | Number of Participants With ECOG Performance Status at C4D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C4D8 therefore, the number of participants is 0. | Posted | Number | Participants | At C4D8 |
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| Primary | Number of Participants With ECOG Performance Status at C4D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation (with dosage ASP7517 1x10^8 cells/dose) and Phase 2 monotherapy dose expansion entered C4D15 therefore, the number of participants is 0. | Posted | Number | Participants | At C4D15 |
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| Primary | Number of Participants With ECOG Performance Status at C5D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D1 therefore, the number of participants is 0. | Posted | Number | Participants | At C5D1 |
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| Primary | Number of Participants With ECOG Performance Status at C5D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D8 therefore, the number of participants is 0. | Posted | Number | Participants | At C5D8 |
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| Primary | Number of Participants With ECOG Performance Status at C5D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D15 therefore, the number of participants is 0. | Posted | Number | Participants | At C5D15 |
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| Primary | Number of Participants With ECOG Performance Status at C6D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D1 therefore, the number of participants is 0. | Posted | Number | Participants | At C6D1 |
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| Primary | Number of Participants With ECOG Performance Status at C6D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D8 therefore, the number of participants is 0. | Posted | Number | Participants | At C6D8 |
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| Primary | Number of Participants With ECOG Performance Status at C6D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D15 therefore, the number of participants is 0. | Posted | Number | Participants | At C6D15 |
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| Primary | Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose. | SAF with available data was analyzed. | Posted | Number | Participants | At EOT (Approximately 511 [504 +7] days) |
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| Primary | Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy. | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose. | SAF with available data was analyzed. | Posted | Number | Participants | At EOT (Approximately 824 [817 +7] days) |
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| Primary | Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered the 30 day follow up period therefore, the number of participants is 0. | Posted | Number | Participants | At 30 days safety Follow Up (Approximately 541 [511+30] days) |
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| Primary | Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At 30 days safety Follow Up (Approximately 854 [824+30 ] days) |
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| Primary | Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. | Posted | Number | Participants | At 60 days safety Follow Up (Approximately 571 [511+60] days) |
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| Primary | Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) entered the 60 day follow up period therefore, the number of participants is 0. | Posted | Number | Participants | At 60 days safety Follow Up (Approximately 884 [824+60] days) |
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| Primary | Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from the Phase 1 monotherapy therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) and Phase 2 monotherapy dose expansion entered the 90 day follow up period therefore, the number of participants is 0. | Posted | Number | Participants | At 90 days safety follow up (Approximately 601 [511+90] days) |
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| Primary | Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. | SAF with available data was analyzed. No participants from the Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10^7 cells/dose) entered the 90 day follow up period therefore, the number of participants is 0. | Posted | Number | Participants | At 90 days safety follow up (Approximately 914 [824+90] days) |
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| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT: any event occurring within 28 days of first dose on C1D1 and graded as: *Non-hematologic AEs >= grade 3 and not resolving to <= grade 2 within 72 hours. *Confirmed Hy's law case. *Infusion-related reactions requiring infusion discontinuation, prolonged delay (> 2 weeks) in initiating C2 due to treatment-related toxicity. *Any treatment-related toxicity causing discontinuation in C1. *Grade >= 3 thrombocytopenia/bleeding requiring transfusion/hospitalization, grade >= 3 anemia requiring transfusion, grade 3 febrile neutropenia with/without infection and grade 5 treatment-related toxicity, grade >= 2 pneumonitis, grade >= 2 encephalopathy, meningitis or motor/sensory neuropathy. *Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) in participants without liver metastases, AST/ALT > 8×ULN in participants with liver metastases, total bilirubin > 3×ULN (grade >= 3). *Guillain-Barré syndrome/myasthenic syndrome/myasthenia gravis. | The DLT evaluation analysis set (DEAS) consisted of all participants in SAF excluding participants who met any of the following criteria:
DLTs were analyzed only in Phase 1 . | Posted | Number | Participants | From C1D1 up to C1D28 |
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| Primary | Objective Response Rate (iORR) Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator Assessment | iORR was defined as the percentage of participants for each dose level whose best overall response was rated as confirmed iCR or iPR per iRECIST by independent central review. iCR was complete response based on iRECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iORR assessments included:
| Response analysis set (RAS) consisted of all participants who were enrolled and received at least 1 dose of investigational product (IP) and had at least 1 postbaseline primary efficacy measurement. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to 954 days |
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| Secondary | Objective Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment | ORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. CR was complete response based on RECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. ORR assessment included:
| RAS | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to 954 days |
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| Secondary | Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment | iDCR: Percentage of participants for each dose level whose best overall response is rated as confirmed iCR, iPR or iSD per iRECIST. iCR: Complete response based on iRECIST, defined as disappearance of all target/non target lesions and pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR: Partial response based on iRECIST, defined as at least 30% decrease in the sum of diameters of target lesions, with reference to the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: Defined as at least 20% increase in the sum of diameters of target lesions, with reference to the smallest sum of diameters recorded since the treatment started. For confirmed response for iCR/iPR, scan had to be done 4 weeks after iPR/iCR was first observed. Participants who had iCR/iPR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response. | RAS | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to 954 days |
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| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 by Investigator Assessment | DCR: Percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1. CR: Complete response based on RECIST and defined as disappearance of all target/non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR: Partial response based on RECIST and defined as at least a 30% decrease in the sum of diameters of target lesions, with reference to, the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, with reference to, the smallest sum of diameters recorded since treatment started. For confirmed response for CR/PR, scan had to be done 4 weeks after PR/CR was first observed. Participants who had CR/PR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response. | RAS | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to 954 days |
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| Secondary | Progression-Free Survival Per iRECIST (iPFS) Using Investigator Assessment | iPFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST by independent central review and investigator assessment, whichever occurs first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints. | Full analysis set (FAS) consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | days | From first dose until death from any cause or radiographic disease progression (up to 954 days) |
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| Secondary | Progression-Free Survival Per RECIST (PFS) Using Investigator Assessment | PFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST by independent central review and investigator assessment, whichever occurred first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints. | FAS | Posted | Median | 95% Confidence Interval | days | From first dose until death from any cause or radiographic disease progression (up to 954 days) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1). Kaplan Meier estimate was used for analysis of time-to-event endpoints. | FAS | Posted | Median | 95% Confidence Interval | days | From first dose until death from any cause (up to 954 days) |
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| Secondary | Duration of Response Per iRECIST (iDOR) | iDOR was defined as the time from the date of the first response iCR/iPR (whichever was first recorded) to the date of radiographical progression or date of censoring. iCR was complete response based on iRECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | No participant had a response of iCR or iPR and therefore iDOR was not evaluable. | Posted | From first response up to the date of radiographical progression (up to 954 days) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST v1.1 | DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1, separately for independent central review and for investigator assessment. CR was complete response based on RECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | No participant had a response of CR or PR and therefore DOR was not evaluable. | Posted | From first response up to the date of radiographical progression (up to 954 days) |
|
Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) | Participants received one dose of ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. | 3 | 8 | 2 | 8 | 7 | 8 |
| EG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) | 1 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. | 1 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Catheter site rash | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Metastases to skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vaginal ulceration | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Inc | 08008887704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Jun 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 1 |
|
| Grade 2 |
|
Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| Title | Measurements |
|---|---|
|
| OG001 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
|
|
| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
|
|
| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
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| OG001 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
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| OG001 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
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| OG001 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
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| OG001 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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| OG001 | Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) | Participants received one dose of ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days. |
| OG002 | Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose) | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.) |
| OG003 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
| OG004 | Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab | Participants received ASP7517 1x10^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days. |
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