Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02601313

Acronym

ZUMA-2

Enrollment

105

Registered

2015-11-10

Start date

2015-11-09

Completion date

2023-09-22

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Mantle Cell Lymphoma

Brief summary

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Detailed description

Study KTE-C19-102 enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement, Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi. The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, details for Cohort 3 were registered separately (NCT04880434) on ClinicalTrials.gov as this cohort will not be part of the main study analysis. After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Interventions

BIOLOGICALbrexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells

DRUGCyclophosphamide

Administered intravenously

DRUGFludarabine

Administered intravenously

DRUGAxicabtagene Ciloleucel

A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included: * Anthracycline or bendamustine-containing chemotherapy and * Anti-CD20 monoclonal antibody therapy and * Ibrutinib or acalabrutinib At least 1 measurable lesion Platelet count ≥ 75,000/uL Creatinine clearance (as estimated by Cockcroft Gault) \> or = to 60 mL/min Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings Baseline oxygen saturation \>92% on room air. Key

Exclusion criteria

* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing * History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1	Up to 7.8 years	OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤ mediastinum)/3(uptake \> mediastinum but ≤ liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.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;bone marrow normal by morphology. PMR:score 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 the 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.
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2	Up to 7.8 years	OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake \> mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi; no extralymphatic sites of disease;absent non-measured lesion NMLs; organ enlargement regress to normal; no new sites; bone marrow normal by morphology. PMR: score 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 EOT. PRR: ≥ 50% decrease in 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. Percentages were rounded off.

Secondary

Measure	Time frame	Description
Duration of Response (DOR) in Cohort 1 as Per Investigator Response	Up to 7.8 years	DOR: time from the first OR to progressive disease (PD)/death. It is determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately \> liver)/ 5 (uptake markedly \>liver and/or new lesions) with an 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 or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the 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.
Duration of Response (DOR) in Cohort 2 as Per Investigator Response	Up to 7.8 years	DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately \> liver)/5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new 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 PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the 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.
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	Up to 7.8 years	BOR consists of (Complete response \[CR\], Partial response \[PR\], stable disease \[SD\], progressive disease \[PD\] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. Percentages were rounded off.
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	Up to 7.8 years	BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. Not done: no assessment at the time of analysis. Percentages were rounded off. Only categories with data are reported.
Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	Up to 7.8 years	OR: CR or PR. CR: disappearance of all detectable clinical evidence; typically FDG-avid lymphoma (a post-treatment residual mass of any size is permitted if it is PET negative); variably FDG-avid lymphomas/FDG avidity unknown (all lymph nodes and nodal masses must have regressed to normal size); spleen and/or liver should be normal size and not be palpable; bone marrow aspirate and biopsy must show no evidence of disease. PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and ≥ 50% decrease in SPD of spleen/liver nodules; no increase in size of nodes, liver, or spleen and no new sites of disease; splenic and hepatic nodules must regress by ≥ 50% in the SPD; if participant has persistent bone marrow involvement and otherwise meets criteria for CR, will then be considered a PR; typically FDG-avid lymphoma (the post-treatment PET scan should be positive in at least 1 previously involved site. Percentages were rounded off.
Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	Up to 7.8 years	OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake \> mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. 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 normal by morphology. PMR: score 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 EOT. PRR: ≥ 50% decrease in 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. Percentages were rounded off.
Progression Free Survival (PFS) in Cohort 1 as Per Investigator Response.	Up to 7.8 years	PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately \> liver) or 5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates.
Progression Free Survival (PFS) in Cohort 2 as Per Investigator Response.	Up to 7.8 years	PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately \> liver) or 5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates.
Overall Survival in Cohort 1	Up to 7.8 years	Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
Overall Survival in Cohort 2	Up to 7.8 years	Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)	Up to 5 years	An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. AE included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an AE. TEAE was defined as any AE with onset on or after the start of treatment.
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Up to 5 years	—
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Up to 5 years	—
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Up to 5 years	—
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Up to 5 years	—
Percentage of Participants With Anti-CD19 CAR Antibodies	Baseline up to Month 3	—
Maximum Number of CAR T Cells Measured Post-infusion	Up to Month 24	—
Peak Serum Levels of C-Reactive Protein (CRP) in Blood	Baseline up to Week 4	Peak was defined as the maximum post-baseline level of the cytokine.
Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	Baseline up to Week 4	Peak was defined as the maximum post-baseline level of the cytokine.
Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	Baseline up to Week 4	Peak was defined as the maximum post-baseline level of the cytokine.
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline, Week 4, Month 3, and Month 6	The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline, Week 4, Month 3, and Month 6	The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline, Week 4, Month 3, and Month 6	The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline, Week 4, Month 3, and Month 6	The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline, Week 4, Month 3, and Month 6	The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported. Percentages were rounded off.
Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Baseline, Week 4, Month 3, and Month 6	EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement.

Countries

France, Germany, Netherlands, United States

Contacts

STUDY_DIRECTORKite Study Director

Kite, A Gilead Company

Participant flow

Recruitment details

Participants were enrolled at study sites in United States, France, Netherlands and Germany.

Pre-assignment details

Participants from 2 x 10\^6 axicabtagene ciloleucel (AC) didn't contribute to primary and secondary analysis. The process used to manufacture axicabtagene ciloleucel was modified to manufacture brexucabtagene autoleucel (KTE-X19).

Participants by arm

Arm	Count
2 x 10^6 Axicabtagene Ciloleucel Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg on Day 0.	10
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.	68
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.	14
Total	92

Baseline characteristics

Characteristic	Total	2 x 10^6 Axicabtagene Ciloleucel	Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
Age, Customized < 65 years	44 Participants	4 Participants	29 Participants	11 Participants
Age, Customized >= 65 years	48 Participants	6 Participants	39 Participants	3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	0 Participants	11 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants	9 Participants	55 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Race Black or African American	1 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander	1 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Race Others	5 Participants	0 Participants	4 Participants	1 Participants
Race/Ethnicity, Customized Race White	85 Participants	10 Participants	62 Participants	13 Participants
Region of Enrollment France	3 participants	0 participants	3 participants	0 participants
Region of Enrollment Germany	1 participants	0 participants	1 participants	0 participants
Region of Enrollment Netherlands	2 participants	0 participants	2 participants	0 participants
Region of Enrollment United States	86 participants	10 participants	62 participants	14 participants
Sex: Female, Male Female	15 Participants	1 Participants	11 Participants	3 Participants
Sex: Female, Male Male	77 Participants	9 Participants	57 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	9 / 14	42 / 74	9 / 17	5 / 5	0 / 1
other Total, other adverse events	10 / 10	68 / 68	14 / 14	5 / 5	1 / 1
serious Total, serious adverse events	8 / 10	49 / 68	9 / 14	3 / 5	0 / 1

Outcome results

Primary

Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1

OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤ mediastinum)/3(uptake \> mediastinum but ≤ liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.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;bone marrow normal by morphology. PMR:score 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 the 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.

Time frame: Up to 7.8 years

Population: mITT set included all participants enrolled and treated with anti-CD19 CAR T cells at any dose in Cohort 1. Percentages were rounded off.

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1	91 percentage of participants

Primary

Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2

OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake \> mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi; no extralymphatic sites of disease;absent non-measured lesion NMLs; organ enlargement regress to normal; no new sites; bone marrow normal by morphology. PMR: score 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 EOT. PRR: ≥ 50% decrease in 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. Percentages were rounded off.

Time frame: Up to 7.8 years

Population: The Modified intent to Treat (mITT) analysis set included all enrolled participants treated with any dose of anti-CD19 CAR T cells in Cohort 2

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2	93 percentage of participants

Secondary

Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score

EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants from the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Month 6	84.3 scores on the scale	Standard Deviation 16.9
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Baseline	82.0 scores on the scale	Standard Deviation 15.4
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Week 4	74.5 scores on the scale	Standard Deviation 15.6
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Month 3	80.2 scores on the scale	Standard Deviation 15.5
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Month 3	86.4 scores on the scale	Standard Deviation 11
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Month 6	89.9 scores on the scale	Standard Deviation 8
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Week 4	71.4 scores on the scale	Standard Deviation 19.4
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score	Baseline	82.8 scores on the scale	Standard Deviation 16.1

Secondary

Duration of Response (DOR) in Cohort 1 as Per Investigator Response

DOR: time from the first OR to progressive disease (PD)/death. It is determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately \> liver)/ 5 (uptake markedly \>liver and/or new lesions) with an 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 or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the 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.

Time frame: Up to 7.8 years

Population: Participants from the mITT analysis Set with objective response and available data in Cohort 1 were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Duration of Response (DOR) in Cohort 1 as Per Investigator Response	36.5 months

Secondary

Duration of Response (DOR) in Cohort 2 as Per Investigator Response

DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately \> liver)/5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new 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 PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the 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.

Time frame: Up to 7.8 years

Population: Participants from the mITT analysis Set with objective response in Cohort 2 were analyzed. Participants not meeting the criteria for DOR at the time of data analysis were censored at their last evaluable disease assessment date.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Duration of Response (DOR) in Cohort 2 as Per Investigator Response	57.5 months

Secondary

Maximum Number of CAR T Cells Measured Post-infusion

Time frame: Up to Month 24

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Maximum Number of CAR T Cells Measured Post-infusion	313.02 cells/μL	Standard Deviation 586.17
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Maximum Number of CAR T Cells Measured Post-infusion	96.69 cells/μL	Standard Deviation 109.33

Secondary

Overall Survival in Cohort 1

Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 1 were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Overall Survival in Cohort 1	46.5 months

Secondary

Overall Survival in Cohort 2

Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 2 were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Overall Survival in Cohort 2	NA months

Secondary

Peak Serum Levels of C-Reactive Protein (CRP) in Blood

Peak was defined as the maximum post-baseline level of the cytokine.

Time frame: Baseline up to Week 4

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-Reactive Protein (CRP) in Blood	4 mg/L
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-Reactive Protein (CRP) in Blood	4 mg/L

Secondary

Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood

Peak was defined as the maximum post-baseline level of the cytokine.

Time frame: Baseline up to Week 4

Population: Participants in the Safety Analysis Set were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-1 RA	1782.65 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-7	32.20 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IFN-gamma	410.25 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-8	41.19 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-2	5.85 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-10	16.55 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	Granzyme B	40.60 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-15	40.30 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-6	86.00 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	TNF alpha	9.50 pg/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	CXCL10	2000.00 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	TNF alpha	10.85 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	CXCL10	2000.00 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	Granzyme B	24.60 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IFN-gamma	442.75 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-1 RA	1783.05 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-2	6.70 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-6	50.70 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-7	31.80 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-8	53.20 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-10	246.10 pg/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood	IL-15	35.60 pg/mL

Secondary

Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood

Peak was defined as the maximum post-baseline level of the cytokine.

Time frame: Baseline up to Week 4

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	IL-2 R alpha	18.72 ng/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	Perforin	18.71 ng/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	ICAM-1	1252.07 ng/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	VCAM-1	1843.57 ng/mL
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	Ferritin	1302.41 ng/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	VCAM-1	1829.69 ng/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	Ferritin	1126.52 ng/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	IL-2 R alpha	23.95 ng/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	ICAM-1	1033.85 ng/mL
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood	Perforin	13.84 ng/mL

Secondary

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. AE included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an AE. TEAE was defined as any AE with onset on or after the start of treatment.

Time frame: Up to 5 years

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)	100 percentage of participants

Secondary

Percentage of Participants With Anti-CD19 CAR Antibodies

Time frame: Baseline up to Month 3

Population: Participants from the Safety Analysis Set were analyzed

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Anti-CD19 CAR Antibodies	21 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Anti-CD19 CAR Antibodies	21 percentage of participants

Secondary

Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1

BOR consists of (Complete response \[CR\], Partial response \[PR\], stable disease \[SD\], progressive disease \[PD\] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. Percentages were rounded off.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 1 were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	CR	67.6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	PR	20.6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	Stable disease	8.8 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	Progressive disease	2.9 percentage of participants

Secondary

Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2

BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. Not done: no assessment at the time of analysis. Percentages were rounded off. Only categories with data are reported.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 2 were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	CR	64.3 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	PR	21.4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	Stable disease	7.1 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	Not done	7.1 percentage of participants

Secondary

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported. Percentages were rounded off.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants from the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Not anxious or depressed	75 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Slight anxious or depressed	20 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Moderate anxious or depressed	5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Severe anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Extreme anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Not anxious or depressed	67 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Slight anxious or depressed	26 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Moderate anxious or depressed	6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Severe anxious or depressed	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Extreme anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Not anxious or depressed	70 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Slight anxious or depressed	21 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Moderate anxious or depressed	9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Severe anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Extreme anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Not anxious or depressed	63 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Slight anxious or depressed	26 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Moderate anxious or depressed	11 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Severe anxious or depressed	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Extreme anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Moderate anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Not anxious or depressed	67 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Not anxious or depressed	91 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Slight anxious or depressed	33 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Not anxious or depressed	90 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Moderate anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Slight anxious or depressed	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Severe anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Extreme anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Baseline: Extreme anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Moderate anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Not anxious or depressed	73 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Slight anxious or depressed	10 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Slight anxious or depressed	27 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Severe anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Moderate anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 6: Severe anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Severe anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Month 3: Extreme anxious or depressed	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score	Week 4: Extreme anxious or depressed	0 percentage of participants

Secondary

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants from the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: No problems walking	85 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Slight problems walking	11 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Moderate problems walking	3 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Severe problems walking	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Unable to walk	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: No problems walking	49 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Slight problems walking	33 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Moderate problems walking	6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Severe problems walking	8 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Unable to walk	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: No problems walking	69 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Slight problems walking	18 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Moderate problems walking	7 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Severe problems walking	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Unable to walk	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: No problems walking	75 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Slight problems walking	14 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Moderate problems walking	7 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Severe problems walking	5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Unable to walk	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Moderate problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: No problems walking	83 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: No problems walking	91 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Slight problems walking	17 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: No problems walking	90 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Moderate problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Slight problems walking	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Severe problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Unable to walk	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Baseline: Unable to walk	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Moderate problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: No problems walking	73 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Slight problems walking	10 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Slight problems walking	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Severe problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Moderate problems walking	18 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 6: Severe problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Severe problems walking	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Month 3: Unable to walk	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score	Week 4: Unable to walk	0 percentage of participants

Secondary

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants in the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: No pain or discomfort	66 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Slight pain or discomfort	22 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Moderate pain or discomfort	9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Severe pain or discomfort	3 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Extreme pain or discomfort	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: No pain or discomfort	63 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Slight pain or discomfort	19 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Moderate pain or discomfort	19 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Severe pain or discomfort	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Extreme pain or discomfort	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: No pain or discomfort	61 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Slight pain or discomfort	16 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Moderate pain or discomfort	18 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Severe pain or discomfort	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Extreme pain or discomfort	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: No pain or discomfort	65 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Slight pain or discomfort	24 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Moderate pain or discomfort	9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Severe pain or discomfort	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Extreme pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Moderate pain or discomfort	20 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: No pain or discomfort	75 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: No pain or discomfort	64 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Slight pain or discomfort	8 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: No pain or discomfort	70 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Moderate pain or discomfort	17 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Slight pain or discomfort	27 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Severe pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Extreme pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Baseline: Extreme pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Moderate pain or discomfort	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: No pain or discomfort	64 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Slight pain or discomfort	10 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Slight pain or discomfort	18 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Severe pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Moderate pain or discomfort	18 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 6: Severe pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Severe pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Month 3: Extreme pain or discomfort	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score	Week 4: Extreme pain or discomfort	0 percentage of participants

Secondary

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants from the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: No problems washing or dressing,	95 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Slight problems washing or dressing	3 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Moderate problems washing or dressing	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Severe problems washing or dressing	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Unable to wash or dress	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: No problems washing or dressing,	67 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Slight problems washing or dressing	17 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Moderate problems washing or dressing	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Severe problems washing or dressing	8 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Unable to wash or dress	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: No problems washing or dressing,	84 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Slight problems washing or dressing	11 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Moderate problems washing or dressing	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Severe problems washing or dressing	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Unable to wash or dress	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: No problems washing or dressing,	93 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Slight problems washing or dressing	2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Moderate problems washing or dressing	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Severe problems washing or dressing	5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Unable to wash or dress	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Moderate problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: No problems washing or dressing,	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: No problems washing or dressing,	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Slight problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: No problems washing or dressing,	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Moderate problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Slight problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Severe problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Unable to wash or dress	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Baseline: Unable to wash or dress	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Moderate problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: No problems washing or dressing,	91 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Slight problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Slight problems washing or dressing	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Severe problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Moderate problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 6: Severe problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Severe problems washing or dressing	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Month 3: Unable to wash or dress	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score	Week 4: Unable to wash or dress	0 percentage of participants

Secondary

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported. Percentages were rounded off.

Time frame: Baseline, Week 4, Month 3, and Month 6

Population: Participants from the Safety Analysis Set with available data were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: No problems doing usual activities	82 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Slight problems doing usual activities	14 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Moderate problems doing usual activities	5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Severe problems doing usual activities	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Unable to do usual activities	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: No problems doing usual activities	43 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Slight problems doing usual activities	24 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Moderate problems doing usual activities	22 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Severe problems doing usual activities	6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Unable to do usual activities	6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: No problems doing usual activities	70 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Slight problems doing usual activities	16 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Moderate problems doing usual activities	7 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Severe problems doing usual activities	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Unable to do usual activities	4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: No problems doing usual activities	73 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Slight problems doing usual activities	16 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Moderate problems doing usual activities	9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Severe problems doing usual activities	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Unable to do usual activities	2 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Moderate problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: No problems doing usual activities	75 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: No problems doing usual activities	64 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Slight problems doing usual activities	17 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: No problems doing usual activities	70 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Moderate problems doing usual activities	8 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Slight problems doing usual activities	36 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Severe problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Unable to do usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Baseline: Unable to do usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Moderate problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: No problems doing usual activities	36 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Slight problems doing usual activities	30 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Slight problems doing usual activities	55 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Severe problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Moderate problems doing usual activities	9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 6: Severe problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Severe problems doing usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Month 3: Unable to do usual activities	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score	Week 4: Unable to do usual activities	0 percentage of participants

Secondary

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade

Time frame: Up to 5 years

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Magnesium	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Albumin	7.4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Calcium	17.6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Glucose	1.5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Sodium	13.2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Phosphate	30.9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Potassium	10.3 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Phosphate	28.6 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Potassium	7.1 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Calcium	35.7 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Magnesium	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Sodium	28.6 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Albumin	7.1 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in Glucose	7.1 percentage of participants

Secondary

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

Time frame: Up to 5 years

Population: Participants from the Safety Analysis set were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in neutrophils	98.5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in leukocytes	98.5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in platelets	61.8 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in lymphocytes	95.6 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in hemoglobin	55.9 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in lymphocytes	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in hemoglobin	57.1 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in neutrophils	100 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in platelets	78.6 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher decrease in leukocytes	92.9 percentage of participants

Secondary

Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade

Time frame: Up to 5 years

Population: Participants from the Safety Analysis Set were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Potassium	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Calcium	0 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Magnesium	2.9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Sodium	4.4 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Alanine aminotransferase	14.7 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Aspartate aminotransferase	14.7 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Bilirubin	1.5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Creatinine	5.9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Urate	16.2 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Direct bilirubin	2.9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Glucose	5.9 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Alkaline phosphatase	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Glucose	21.4 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Potassium	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Bilirubin	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Calcium	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Direct bilirubin	14.3 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Magnesium	7.1 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Creatinine	7.1 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Sodium	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Alkaline phosphatase	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Alanine aminotransferase	14.3 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Urate	21.4 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in Aspartate aminotransferase	14.3 percentage of participants

Secondary

Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

Time frame: Up to 5 years

Population: Participants from Safety Analysis Set were analyzed.

Arm	Measure	Group	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in leukocytes	1.5 percentage of participants
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in lymphocytes	1.5 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in leukocytes	0 percentage of participants
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade	Grade 3 or higher increase in lymphocytes	0 percentage of participants

Secondary

Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1

OR: CR or PR. CR: disappearance of all detectable clinical evidence; typically FDG-avid lymphoma (a post-treatment residual mass of any size is permitted if it is PET negative); variably FDG-avid lymphomas/FDG avidity unknown (all lymph nodes and nodal masses must have regressed to normal size); spleen and/or liver should be normal size and not be palpable; bone marrow aspirate and biopsy must show no evidence of disease. PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and ≥ 50% decrease in SPD of spleen/liver nodules; no increase in size of nodes, liver, or spleen and no new sites of disease; splenic and hepatic nodules must regress by ≥ 50% in the SPD; if participant has persistent bone marrow involvement and otherwise meets criteria for CR, will then be considered a PR; typically FDG-avid lymphoma (the post-treatment PET scan should be positive in at least 1 previously involved site. Percentages were rounded off.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 1 were analyzed.

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1	88 percentage of participants

Secondary

Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2

OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake \> mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. 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 normal by morphology. PMR: score 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 EOT. PRR: ≥ 50% decrease in 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. Percentages were rounded off.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 2 were analyzed.

Arm	Measure	Value (NUMBER)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2	86 percentage of participants

Secondary

Progression Free Survival (PFS) in Cohort 1 as Per Investigator Response.

PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately \> liver) or 5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 1 were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Progression Free Survival (PFS) in Cohort 1 as Per Investigator Response.	25.3 months

Secondary

Progression Free Survival (PFS) in Cohort 2 as Per Investigator Response.

Time frame: Up to 7.8 years

Population: Participants from the mITT Analysis Set in Cohort 2 were analyzed.

Arm	Measure	Value (MEDIAN)
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	Progression Free Survival (PFS) in Cohort 2 as Per Investigator Response.	29.5 months

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1

Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2

Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score

Duration of Response (DOR) in Cohort 1 as Per Investigator Response

Duration of Response (DOR) in Cohort 2 as Per Investigator Response

Maximum Number of CAR T Cells Measured Post-infusion

Overall Survival in Cohort 1

Overall Survival in Cohort 2

Peak Serum Levels of C-Reactive Protein (CRP) in Blood

Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood

Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

Percentage of Participants With Anti-CD19 CAR Antibodies

Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1

Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade

Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1

Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2

Progression Free Survival (PFS) in Cohort 1 as Per Investigator Response.

Progression Free Survival (PFS) in Cohort 2 as Per Investigator Response.