Trial Outcomes & Findings for Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma (NCT NCT03704298)
NCT ID: NCT03704298
Last Updated: 2024-06-28
Results Overview
DLTs are study drug-related events with onset within first 28 days following infusion of axicabtagene ciloleucel or utomilumab: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia or B-cell aplasia) * All study drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1 within 2 weeks or baseline within 4 weeks, fever of any grade, immediate study drug-related hypersensitivity reactions within 2 hours of drug infusion that are reversible to grade 2 or less within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, grade 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, grade 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, grade 3 nausea and/or anorexia).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-06-28
Participant Flow
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.
17 participants were screened.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
1
|
0
|
|
Overall Study
Rollover to Long-term Follow-up Study Criteria
|
1
|
2
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Developed Other Infection Before Starting the Treatment
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
66 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
63 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: 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.
DLTs are study drug-related events with onset within first 28 days following infusion of axicabtagene ciloleucel or utomilumab: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia or B-cell aplasia) * All study drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1 within 2 weeks or baseline within 4 weeks, fever of any grade, immediate study drug-related hypersensitivity reactions within 2 hours of drug infusion that are reversible to grade 2 or less within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, grade 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, grade 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, grade 3 nausea and/or anorexia).
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Due to early termination of the study, Phase 2 of study was not conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first infusion date of axicabtagene ciloleucel until first occurrence of CR or PR (maximum duration: 42.6 months)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Objective Response Rate (ORR)
|
67 percentage of participants
|
33 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=2 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=1 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Duration of Response (DOR)
|
20.6 months
Interval 18.0 to 23.0
|
22.1 months
Interval 22.1 to 22.1
|
11.0 months
Interval 5.0 to 24.0
|
17.3 months
Interval 5.0 to 23.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Progression Free Survival (PFS)
|
23.8 months
Interval 3.0 to 43.0
|
1.0 months
Interval 1.0 to 35.0
|
12.0 months
Interval 6.0 to 36.0
|
19.9 months
Interval 6.0 to 24.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Overall Survival (OS)
|
41.2 months
Interval 5.0 to 43.0
|
35.1 months
Interval 3.0 to 41.0
|
35.7 months
Interval 30.0 to 36.0
|
24.4 months
Interval 20.0 to 26.0
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (maximum duration: 23.0 months)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (maximum duration: 23.0 months)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Glucose
|
33 percentage of participants
|
33 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Aspartate Aminotransferase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Bilirubin
|
0 percentage of participants
|
33 percentage of participants
|
33 percentage of participants
|
0 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Direct Bilirubin
|
33 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Urate
|
33 percentage of participants
|
67 percentage of participants
|
67 percentage of participants
|
0 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Creatinine
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Calcium
|
0 percentage of participants
|
67 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Magnesium
|
0 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (maximum duration: 23.0 months)Population: 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.
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.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Hemoglobin
|
33 percentage of participants
|
33 percentage of participants
|
100 percentage of participants
|
67 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Lymphocytes
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Neutrophils
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Platelets
|
33 percentage of participants
|
33 percentage of participants
|
67 percentage of participants
|
67 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Leukocytes
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Calcium
|
0 percentage of participants
|
33 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Phosphate
|
0 percentage of participants
|
33 percentage of participants
|
33 percentage of participants
|
33 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Sodium
|
33 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
|
Phase 1 and Phase 2: Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Potassium
|
0 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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 24Population: 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.
Peak was defined as the maximum number of CAR T cells in blood measured after infusion.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Pharmacokinetics: Peak Levels of Axicabtagene Ciloleucel in Blood
|
11.99 cells/μL
Interval 6.69 to 37.21
|
69.48 cells/μL
Interval 36.98 to 996.87
|
149.40 cells/μL
Interval 37.08 to 230.27
|
30.23 cells/μL
Interval 16.63 to 103.38
|
SECONDARY outcome
Timeframe: Baseline, Day 0, Day 7, Week 2, Week 4 (Pre and Post-UTO Dose 2)Population: 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.
Peak is defined as the maximum post-baseline level of cytokine in the blood.
Outcome measures
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 Participants
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 Participants
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 Participants
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 Participants
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.
|
|---|---|---|---|---|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
IL-1 RA
|
454.40 pg/mL
Interval 339.9 to 1551.1
|
1100.00 pg/mL
Interval 1006.0 to 1661.0
|
1578.00 pg/mL
Interval 607.0 to 1639.0
|
2140.00 pg/mL
Interval 901.0 to 9000.0
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
IL-8
|
31.70 pg/mL
Interval 19.6 to 95.2
|
48.70 pg/mL
Interval 23.2 to 63.3
|
121.60 pg/mL
Interval 30.3 to 122.2
|
291.40 pg/mL
Interval 36.8 to 750.0
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
TNF Alpha
|
2.70 pg/mL
Interval 1.7 to 6.0
|
7.30 pg/mL
Interval 3.1 to 11.2
|
4.00 pg/mL
Interval 3.5 to 8.7
|
4.10 pg/mL
Interval 1.8 to 17.5
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
CXCL10
|
763.60 pg/mL
Interval 685.5 to 1794.8
|
2000.00 pg/mL
Interval 1575.6 to 2000.0
|
865.60 pg/mL
Interval 494.3 to 2000.0
|
2000.00 pg/mL
Interval 616.9 to 2000.0
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
Granzyme B
|
7.50 pg/mL
Interval 6.6 to 19.2
|
42.20 pg/mL
Interval 5.7 to 106.7
|
14.00 pg/mL
Interval 4.3 to 44.9
|
13.60 pg/mL
Interval 11.2 to 74.9
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
IFN-gamma
|
40.30 pg/mL
Interval 15.5 to 237.3
|
118.00 pg/mL
Interval 76.2 to 303.3
|
216.60 pg/mL
Interval 207.0 to 1876.0
|
761.90 pg/mL
Interval 56.3 to 1876.0
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
IL-2
|
0.90 pg/mL
Interval 0.9 to 7.4
|
4.70 pg/mL
Interval 3.5 to 8.6
|
27.70 pg/mL
Interval 19.2 to 44.2
|
24.90 pg/mL
Interval 5.5 to 87.1
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
IL-6
|
3.80 pg/mL
Interval 1.6 to 26.4
|
111.20 pg/mL
Interval 35.6 to 269.8
|
65.80 pg/mL
Interval 19.5 to 897.4
|
976.00 pg/mL
Interval 8.0 to 976.0
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
GM-CSF
|
1.90 pg/mL
Interval 1.9 to 1.9
|
1.90 pg/mL
Interval 1.9 to 1.9
|
1.90 pg/mL
Interval 1.9 to 5.9
|
7.50 pg/mL
Interval 1.9 to 79.7
|
|
Phase 1 and Phase 2: Pharmacodynamics: Peak Levels of Cytokines in Serum
MCP-1
|
1063.30 pg/mL
Interval 788.6 to 1143.1
|
1496.20 pg/mL
Interval 415.0 to 1500.0
|
1500.00 pg/mL
Interval 837.1 to 1500.0
|
1500.00 pg/mL
Interval 956.0 to 1500.0
|
Adverse Events
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Chest pain
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
Other adverse events
| Measure |
Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg
n=3 participants at risk
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.
|
Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg
n=3 participants at risk
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.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • 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.
|
66.7%
2/3 • 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.
|
66.7%
2/3 • 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.
|
66.7%
2/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • 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.
|
100.0%
3/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Eye disorders
Visual impairment
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
33.3%
1/3 • 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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Catheter site pain
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Chills
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
100.0%
3/3 • 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.
|
33.3%
1/3 • 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Oedema
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Pain
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • 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.
|
100.0%
3/3 • 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.
|
100.0%
3/3 • 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.
|
66.7%
2/3 • 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.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Covid-19
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
|
Infections and infestations
Cytomegalovirus infection
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
|
Infections and infestations
Viraemia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
100.0%
3/3 • 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.
|
100.0%
3/3 • 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.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
100.0%
3/3 • 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.
|
33.3%
1/3 • 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.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
Weight increased
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
33.3%
1/3 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • 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.
|
0.00%
0/3 • 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.
|
33.3%
1/3 • 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.
|
66.7%
2/3 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
Additional Information
Medical Information
Kite, A Gilead Company
Phone: 844-454-5483 (1-844-454-KITE)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER