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Development program terminated
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The primary objectives of this study are:
Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2
Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma
This study was intended to be a Phase 1/2. Enrollment was stopped prior to completion of Phase 1 portion of the study based on the sponsor's decision to end the program. No participants were enrolled in Phase 1 Cohort 5 and Phase 2.
After the study ends, participants who received an infusion of axicabtagene ciloleucel and utomilumab will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Participants also will receive utomilumab 10 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive disease, whichever came first. |
|
| Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Participants also will receive utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. |
|
| Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Participants also will receive utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Administered according to package insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) | DLTs are study drug-related events with onset within first 28 days following infusion of axicabtagene ciloleucel or utomilumab:
| Up to 28 days |
| Phase 2: Complete Response (CR) Rate | CR Rate: Percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and Phase 2: Objective Response Rate (ORR) | ORR: Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake>mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤1.5 cm in LDi; no extralymphatic sites of disease; absent NMLs;organ enlargement regress to normal; no new sites; bone marrow morphology normal. PMR: scores 4 (uptake moderately > liver),5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal; no new sites. |
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Key Inclusion Criteria:
Histologically proven large B-cell lymphoma including the following types:
Relapsed or chemotherapy-refractory disease, defined as one or more of the following:
No response to first-line therapy (primary refractory disease); individuals who are intolerant to first-line systemic chemotherapy are excluded
No response to second or greater lines of therapy.
Refractory post-autologous stem cell transplant (ASCT).
Relapsed or refractory LBCL including DLBCL, Transformed follicular lymphoma (TFL), and HGBCL after 2 or more lines of systemic therapy that is defined by and aligns with currently approved indication:
At least 1 measurable lesion according to the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Individual must have received adequate prior therapy including at a minimum:
No radiographic evidence, suspicion and/or history of central nervous system (CNS) involvement of lymphoma.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Absolute neutrophil count (ANC) ≥ 1000/μL.
Platelet count ≥ 75,000/μL.
Absolute lymphocyte count ≥ 100/μL.
Adequate renal, hepatic, pulmonary, and cardiac function defined as:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States | ||
| UCLA Hematology/ Oncology |
| 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 |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
17 participants were screened.
Participants were enrolled at study sites in the United States. This study was planned to be conducted in 2 parts: Phase 1 and Phase 2. Phase 1 was to be of 5 cohorts. Due to early termination of the study, Cohort 5 and Phase 2 were not conducted and no participants were enrolled in these cohorts. Results are reported only for Phase 1: Cohorts 1-4 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 10 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive disease, whichever came first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 7, 2022 | Nov 10, 2023 |
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|
| Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Participants also will receive utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. |
|
| Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Participants also will receive utomilumab 400 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. However, as the study was early terminated, no participants were enrolled in Cohort 5 of the study. |
|
| Phase 2: Axicabtagene Ciloleucel + Utomilumab | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel and utomilumab based on the dose and schedule selected to move forward from the Phase 1 portion of the study as recommended by the internal safety review team. However, as the study was early terminated, no participants were enrolled in Phase 2 of the study. |
|
| Fludarabine | Drug | Administered according to package insert |
|
| Axicabtagene Ciloleucel | Biological | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously |
|
|
| Utomilumab | Biological | Administered as an IV infusion |
|
| From first infusion date of axicabtagene ciloleucel until first occurrence of CR or PR (maximum duration: 42.6 months) |
| Phase 1 and Phase 2: Duration of Response (DOR) | DOR is time from first objective response (OR) to disease progression (PD)/death from any cause/up to last date known alive in the study. PD:score 4(uptake moderately>liver)/5(uptake markedly>liver and/or new lesions) with increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi >1.5 cm, increase by ≥50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi/shortest axis perpendicular to LDi from nadir, splenic length must increase by >50% of extent of its prior increase beyond baseline. If no prior splenomegaly, increase must be ≥2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement. OR is defined in outcome measure 3. | From first documentation of CR or PR until first occurrence of PD or death from any cause or up to last date known alive in the study (maximum duration: 42.6 months) |
| Phase 1 and Phase 2: Progression Free Survival (PFS) | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of PD per Lugano classification or death from any cause or up to last date known alive in the study. PD is defined in outcome measure 4. | From first infusion date of axicabtagene ciloleucel to the date of PD or death from any cause or up to last date known alive in the study (maximum duration: 43.5 months) |
| Phase 1 and Phase 2: Overall Survival (OS) | OS was defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause or up to last date known alive in the study. | From first infusion date of axicabtagene ciloleucel to date of death from any cause or up to last date known alive in the study (maximum duration: 43.5 months) |
| Phase 1 and Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant in a clinical trial participant, which did not necessarily have a causal relationship with the treatment. TEAEs were defined as any worsening of a pre-existing medical condition that occurred on or after axicabtagene ciloleucel infusion or any AE with onset on or after axicabtagene ciloleucel infusion. | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
| Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
| Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
| Phase 1 and Phase 2: Pharmacokinetics: Peak Levels of Axicabtagene Ciloleucel in Blood | Peak was defined as the maximum number of CAR T cells in blood measured after infusion. | Day 1 (Pre-utomilumab (UTO) Dose 1), Day 3 (Post-UTO Dose 1), Day 7, Day 10, Week 2, Week 3, Week 4 (Pre and Post-UTO Dose 2), Week 8 (Pre and Post-UTO Dose 3), Week 12 (Pre-UTO Dose 4), Week 16 (Pre-UTO Dose 5), Week 20 (Pre-UTO Dose 6), Week 24 |
| Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum | Peak is defined as the maximum post-baseline level of cytokine in the blood. | Baseline, Day 0, Day 7, Week 2, Week 4 (Pre and Post-UTO Dose 2) |
| Santa Monica |
| California |
| 90404 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| FG001 | Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| FG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| FG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| COMPLETED |
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| NOT COMPLETED |
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|
The Safety Analysis Set is defined as all participants treated with any dose of axicabtagene ciloleucel.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 10 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| BG001 | Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| BG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| BG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| BG004 | 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, Categorical | Count of Participants | Participants |
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| 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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| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) | DLTs are study drug-related events with onset within first 28 days following infusion of axicabtagene ciloleucel or utomilumab:
| The DLT evaluable set was defined as participants in each Phase 1 cohort who received the target axicabtagene ciloleucel dose and were followed for at least 28 days after the first utomilumab infusion or who received axicabtagene ciloleucel lower than the target dose for that cohort and a subsequent utomilumab infusion but experienced a DLT within 28 days after utomilumab infusion. No participants were enrolled in Phase 1: Cohort 5, so data is not available for them. | Posted | Number | percentage of participants | Up to 28 days |
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| Primary | Phase 2: Complete Response (CR) Rate | CR Rate: Percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. | Due to early termination of the study, Phase 2 of study was not conducted. | Posted | Up to 1 year |
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| Secondary | Phase 1 and Phase 2: Objective Response Rate (ORR) | ORR: Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake>mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤1.5 cm in LDi; no extralymphatic sites of disease; absent NMLs;organ enlargement regress to normal; no new sites; bone marrow morphology normal. PMR: scores 4 (uptake moderately > liver),5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal; no new sites. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Number | percentage of participants | From first infusion date of axicabtagene ciloleucel until first occurrence of CR or PR (maximum duration: 42.6 months) |
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| Secondary | Phase 1 and Phase 2: Duration of Response (DOR) | DOR is time from first objective response (OR) to disease progression (PD)/death from any cause/up to last date known alive in the study. PD:score 4(uptake moderately>liver)/5(uptake markedly>liver and/or new lesions) with increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi >1.5 cm, increase by ≥50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi/shortest axis perpendicular to LDi from nadir, splenic length must increase by >50% of extent of its prior increase beyond baseline. If no prior splenomegaly, increase must be ≥2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement. OR is defined in outcome measure 3. | Participants in Safety Analysis Set were analyzed. DOR was assessed in participants with an objective response. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Median | Full Range | months | From first documentation of CR or PR until first occurrence of PD or death from any cause or up to last date known alive in the study (maximum duration: 42.6 months) |
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| Secondary | Phase 1 and Phase 2: Progression Free Survival (PFS) | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of PD per Lugano classification or death from any cause or up to last date known alive in the study. PD is defined in outcome measure 4. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Median | Full Range | months | From first infusion date of axicabtagene ciloleucel to the date of PD or death from any cause or up to last date known alive in the study (maximum duration: 43.5 months) |
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| Secondary | Phase 1 and Phase 2: Overall Survival (OS) | OS was defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause or up to last date known alive in the study. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Median | Full Range | months | From first infusion date of axicabtagene ciloleucel to date of death from any cause or up to last date known alive in the study (maximum duration: 43.5 months) |
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| Secondary | Phase 1 and Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant in a clinical trial participant, which did not necessarily have a causal relationship with the treatment. TEAEs were defined as any worsening of a pre-existing medical condition that occurred on or after axicabtagene ciloleucel infusion or any AE with onset on or after axicabtagene ciloleucel infusion. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Number | percentage of participants | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
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| Secondary | Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Number | percentage of participants | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Number | percentage of participants | From first dose up to 30 days post last dose (maximum duration: 23.0 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: Pharmacokinetics: Peak Levels of Axicabtagene Ciloleucel in Blood | Peak was defined as the maximum number of CAR T cells in blood measured after infusion. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Median | Inter-Quartile Range | cells/μL | Day 1 (Pre-utomilumab (UTO) Dose 1), Day 3 (Post-UTO Dose 1), Day 7, Day 10, Week 2, Week 3, Week 4 (Pre and Post-UTO Dose 2), Week 8 (Pre and Post-UTO Dose 3), Week 12 (Pre-UTO Dose 4), Week 16 (Pre-UTO Dose 5), Week 20 (Pre-UTO Dose 6), Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum | Peak is defined as the maximum post-baseline level of cytokine in the blood. | Participants in Safety Analysis Set were analyzed. No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them. | Posted | Median | Full Range | pg/mL | Baseline, Day 0, Day 7, Week 2, Week 4 (Pre and Post-UTO Dose 2) |
|
All-Cause Mortality: Enrollment up to 43.5 months; Adverse events: From first dose up to 30 days post last dose (maximum duration: 23.0 months)
All-cause mortality: Full Analysis Set defined as all enrolled participants who underwent leukapheresis.
Adverse events: Safety Analysis Set defined as all participants treated with any dose of axicabtagene ciloleucel.
No participants were enrolled in Phase 1: Cohort 5 and Phase 2, so data is not available for them.
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: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 10 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive disease, whichever came first. | 3 | 5 | 1 | 3 | 3 | 3 |
| EG001 | Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. | 2 | 4 | 3 | 3 | 3 | 3 |
| EG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive disease, whichever came first. | 0 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory syncytial virus test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Mar 29, 2021 | Nov 10, 2023 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Translational Statistical Analysis Plan | Sep 13, 2021 | Nov 16, 2023 | SAP_002.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C000629083 | axicabtagene ciloleucel |
| C577122 | utomilumab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| 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 |
|
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG001 | Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
|
|
| OG001 | Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
|
|
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
|
|
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
|
|
Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
|
|
Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first.
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
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Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 30 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first.
| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
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| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day IV and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, Q4W for 6 months or until progressive Disease, whichever came first. |
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| OG002 | Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 100 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
| OG003 | Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg | Participants received cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells was administered. Participants also received utomilumab 200 mg on Day 1, IV infusion, once every 4 weeks (Q4W) for 6 months or until progressive Disease, whichever came first. |
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