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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1209-4055 | Other Grant/Funding Number | WHO | |
| 2017-000106-38 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)
This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed.
Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life.
Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of JCAR017 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JCAR017 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Overall Response Rate (ORR) Per Investigator in Cohort 4 | Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 101 | Vienna | 1090 | Austria | |||
| Local Institution - 351 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017.
Cohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment Period - Leukapheresis |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2021 |
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| Overall Response Rate (ORR) Per Investigator in Cohort 5 | Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR):
Complete response unconfirmed (CRu):
Partial response (PR):
| From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Number of Participants With Adverse Events in Cohort 7 | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. | From leukapheresis to end of study (up to approximately 63 months) |
| Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
| From leukapheresis to end of study (up to approximately 63 months) |
| Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). | At Baseline and Day 29 after JCAR017 infusion |
| Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). | At Baseline and Day 29 after JCAR017 infusion |
| From leukapheresis to end of study (up to approximately 63 months) |
| Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
| From leukapheresis to end of study (up to approximately 63 months) |
| Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. | At Baseline and Day 29 after JCAR017 infusion |
| Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. | At Baseline and Day 29 after JCAR017 infusion |
| Overall Response Rate (ORR) in Cohort 7 | ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Complete Response Rate (CRR) | Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT:
Complete response via CT scan:
Complete response (CR) (Cohort 5):
Complete response unconfirmed (CRu) (Cohort 5):
| From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Event Free Survival (EFS) | Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment. Progressive disease (PD):
Progressive Disease (Cohort 5):
| From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months). |
| Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed. Estimated using Kaplan-Meier product-limit estimates. | From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months) |
| Overall Survival (OS) | Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive. Estimated using Kaplan-Meier product-limit estimates. | From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months). |
| Duration of Response (DOR) | DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment. CR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr > 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology. | From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| Maximum Concentration (Cmax) of JCAR017 by qPCR | Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. Quantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | At baseline and up until 24 months post JCAR017 infusion |
| Time to Peak Concentration (Tmax) of JCAR017 by qPCR | Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. Quantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | At baseline and up until 24 months post JCAR017 infusion |
| Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | Area Under the Curve (AUC) represents the total exposure of participants to study drug. Quantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | At baseline and up until 24 months post JCAR017 infusion |
| Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction. | At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed. | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. |
| Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores | The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. |
| Ghent |
| 9000 |
| Belgium |
| Local Institution - 551 | Helsinki | 00029 | Finland |
| Local Institution - 202 | Lille | 59037 | France |
| Local Institution - 203 | Paris | 75475 | France |
| Local Institution - 201 | Pierre-Bénite | 69495 | France |
| Local Institution - 151 | Cologne | 50937 | Germany |
| Local Institution - 152 | Dresden | 01307 | Germany |
| Local Institution - 155 | Heidelberg | 69120 | Germany |
| Local Institution - 154 | München | 81377 | Germany |
| Local Institution - 153 | Ulm | 89081 | Germany |
| Local Institution - 402 | Milan | 20133 | Italy |
| Local Institution - 401 | Torino | 10126 | Italy |
| Local Institution - 601 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution - 602 | Minato-ku | Tokyo | 105-8470 | Japan |
| Local Institution - 301 | Rotterdam | 3015 CE | Netherlands |
| Local Institution - 451 | Barcelona | 08035 | Spain |
| Local Institution - 251 | Bern | 3010 | Switzerland |
| Local Institution - 502 | Manchester | Lancashire | M20 4BX | United Kingdom |
| Local Institution - 501 | London | WC1E 6BT | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy |
JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| FG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| FG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| FG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| FG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
|
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG001 | Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 | Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
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| Primary | Overall Response Rate (ORR) Per Investigator in Cohort 4 | Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
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| Primary | Overall Response Rate (ORR) Per Investigator in Cohort 5 | Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR):
Complete response unconfirmed (CRu):
Partial response (PR):
| All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
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| Primary | Number of Participants With Adverse Events in Cohort 7 | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. | All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only | Posted | Count of Participants | Participants | From leukapheresis to end of study (up to approximately 63 months) |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
| All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only | Posted | Count of Participants | Participants | From leukapheresis to end of study (up to approximately 63 months) |
|
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| Primary | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). | All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only | Posted | Count of Participants | Participants | At Baseline and Day 29 after JCAR017 infusion |
|
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| Primary | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death). | All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only | Posted | Count of Participants | Participants | At Baseline and Day 29 after JCAR017 infusion |
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| Secondary | Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5 | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. | All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only | Posted | Count of Participants | Participants | From leukapheresis to end of study (up to approximately 63 months) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5 | A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:
| All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only | Posted | Count of Participants | Participants | From leukapheresis to end of study (up to approximately 63 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. | All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only | Posted | Count of Participants | Participants | At Baseline and Day 29 after JCAR017 infusion |
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| Secondary | Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5 | JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death. | All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only. | Posted | Count of Participants | Participants | At Baseline and Day 29 after JCAR017 infusion |
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| Secondary | Overall Response Rate (ORR) in Cohort 7 | ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT:
Complete response via CT scan:
Partial response via PET-CT:
Partial response via CT scan:
| All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT:
Complete response via CT scan:
Complete response (CR) (Cohort 5):
Complete response unconfirmed (CRu) (Cohort 5):
| All participants in the JCAR017 treated set. | Posted | Number | 95% Confidence Interval | Percent of Participants | From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment. Progressive disease (PD):
Progressive Disease (Cohort 5):
| All participants in the JCAR017 treated set. | Posted | Median | 95% Confidence Interval | Months | From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months). |
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| Secondary | Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria | Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed. Estimated using Kaplan-Meier product-limit estimates. | All participants in the JCAR017 treated set. | Posted | Median | 95% Confidence Interval | Months | From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive. Estimated using Kaplan-Meier product-limit estimates. | All participants in the JCAR017 treated set. | Posted | Mean | 95% Confidence Interval | Months | From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months). |
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| Secondary | Duration of Response (DOR) | DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment. CR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr > 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology. | All participants in the JCAR017 treated set who achieved a best overall response of complete response (and/ or CRu in cohort 5) or partial response/ remission. | Posted | Median | 95% Confidence Interval | Months | From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months) |
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| Secondary | Maximum Concentration (Cmax) of JCAR017 by qPCR | Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. Quantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Posted | Geometric Mean | Geometric Coefficient of Variation | Copies/ug | At baseline and up until 24 months post JCAR017 infusion |
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| Secondary | Time to Peak Concentration (Tmax) of JCAR017 by qPCR | Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. Quantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Posted | Median | Full Range | Days | At baseline and up until 24 months post JCAR017 infusion |
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| Secondary | Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR | Area Under the Curve (AUC) represents the total exposure of participants to study drug. Quantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene. Baseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion. | All participants in the JCAR017 treated set with baseline and on-study PK measurements. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*copies/ug | At baseline and up until 24 months post JCAR017 infusion |
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| Secondary | Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR | Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction. | All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results. | Posted | Number | Percent of Participants | At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion. |
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| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores | The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed. | All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire. | Posted | Mean | Standard Deviation | Scores on a Scale | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores | The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. | All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire. | Posted | Mean | Standard Deviation | Scores on a Scale | At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion. |
|
Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.
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 | Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 32 | 45 | 19 | 45 | 40 | 45 |
| EG001 | Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 22 | 32 | 8 | 32 | 25 | 32 |
| EG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 9 | 14 | 2 | 14 | 12 | 14 |
| EG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 5 | 7 | 2 | 7 | 5 | 7 |
| EG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). | 4 | 11 | 1 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stupor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired antithrombin III deficiency | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Nov 21, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Adverse Event |
|
| Participant Withdrew from Study |
|
| Physician Decision |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
|
|
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
|
|
JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
|
|
| OG002 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 |
JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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| OG001 | Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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| OG001 | Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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| OG002 | Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG003 | Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG004 | Cohort 5: Primary Central Nervous System Lymphoma | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
| OG005 | Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | JCAR017 was infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy). |
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