Trial Outcomes & Findings for A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (NCT NCT03105336)

Last Updated: 2025-12-23

Results Overview

OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (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.PRR:≥50% decrease in sum of product of diameters up to 6 target 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

159 participants

Primary outcome timeframe

Up to 85.6 months

Results posted on

2025-12-23

Participant Flow

Participants were enrolled at study sites in the United States and France.

189 participants were screened. A total of 159 participants were enrolled. However, one participant discontinued the study as the participant did not meet study condition eligibility criteria (was diagnosed with diffuse large B-cell lymphoma (DLBCL)). So, 158 participants were considered in the Full Analysis Set (FAS = all enrolled participants).

Participant milestones

Participant milestones
Measure	Axicabtagene Ciloleucel (Follicular Lymphoma) Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Overall Study STARTED	127	31
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	127	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Axicabtagene Ciloleucel (Follicular Lymphoma) Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Overall Study Rollover to Longterm Follow-up Study Criteria	61	15
Overall Study Death	40	8
Overall Study Lost to Follow-up	13	2
Overall Study Subject Withdrawal of Consent from Further Follow-up	7	3
Overall Study Reason Not Specified	3	3
Overall Study Investigator Decision	3	0

Baseline Characteristics

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Total n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=68 Participants	15 Participants n=4 Participants	101 Participants n=219 Participants
Age, Categorical >=65 years	38 Participants n=68 Participants	13 Participants n=4 Participants	51 Participants n=219 Participants
Age, Continuous	59 years STANDARD_DEVIATION 9.9 • n=68 Participants	63 years STANDARD_DEVIATION 9.6 • n=4 Participants	60.0 years STANDARD_DEVIATION 10.0 • n=219 Participants
Sex: Female, Male Female	51 Participants n=68 Participants	15 Participants n=4 Participants	66 Participants n=219 Participants
Sex: Female, Male Male	73 Participants n=68 Participants	13 Participants n=4 Participants	86 Participants n=219 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=68 Participants	3 Participants n=4 Participants	9 Participants n=219 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=68 Participants	24 Participants n=4 Participants	142 Participants n=219 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	1 Participants n=4 Participants	1 Participants n=219 Participants
Race/Ethnicity, Customized Race · White	115 Participants n=68 Participants	25 Participants n=4 Participants	140 Participants n=219 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=68 Participants	2 Participants n=4 Participants	6 Participants n=219 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	3 Participants n=68 Participants	1 Participants n=4 Participants	4 Participants n=219 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=68 Participants	0 Participants n=4 Participants	2 Participants n=219 Participants
Region of Enrollment United States	114 Participants n=68 Participants	28 Participants n=4 Participants	142 Participants n=219 Participants
Region of Enrollment France	10 Participants n=68 Participants	0 Participants n=4 Participants	10 Participants n=219 Participants

PRIMARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Full Analysis Set with available data were analyzed. Full Analysis Set consisted of all enrolled participants.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=29 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment	69 percentage of participants Interval 49.0 to 85.0	92 percentage of participants Interval 86.0 to 96.0

SECONDARY outcome

Timeframe: Up to 85.6 months

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

CR is defined in outcome measure (OM)#1. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=29 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With CR Per the Lugano Classification by Central Assessment	52 percentage of participants Interval 33.0 to 71.0	78 percentage of participants Interval 70.0 to 85.0

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed

OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=20 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=80 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy	75 percentage of participants Interval 51.0 to 91.0	91 percentage of participants Interval 83.0 to 96.0

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed

CR is defined as OM#1. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=20 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=80 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy	60 percentage of participants Interval 36.0 to 81.0	79 percentage of participants Interval 68.0 to 87.0

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Full Analysis Set were analyzed.

OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=31 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment	77 percentage of participants Interval 59.0 to 90.0	94 percentage of participants Interval 88.0 to 97.0

SECONDARY outcome

Timeframe: Up to 85.6 months

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

BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (\>) liver) or 5(uptake markedly\>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD: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. Not done:no assessment at time of analysis. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=29 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment PR	17 percentage of participants Interval 6.0 to 36.0	14 percentage of participants Interval 9.0 to 21.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment CR	52 percentage of participants Interval 33.0 to 71.0	78 percentage of participants Interval 70.0 to 85.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment SD	0 percentage of participants Interval 0.0 to 12.0	4 percentage of participants Interval 1.0 to 9.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment PD	3 percentage of participants Interval 0.0 to 18.0	0 percentage of participants Interval 0.0 to 3.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment Non-evaluable	0 percentage of participants Interval 0.0 to 12.0	0 percentage of participants Interval 0.0 to 3.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment Undefined/ No Disease	10 percentage of participants Interval 2.0 to 27.0	1 percentage of participants Interval 0.0 to 4.0
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment Not Done	17 percentage of participants Interval 6.0 to 36.0	3 percentage of participants Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Full Analysis Set were analyzed.

BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=31 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment CR	65 percentage of participants Interval 45.0 to 81.0	79 percentage of participants Interval 71.0 to 85.0
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment PR	13 percentage of participants Interval 4.0 to 30.0	15 percentage of participants Interval 9.0 to 22.0
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment SD	10 percentage of participants Interval 2.0 to 26.0	2 percentage of participants Interval 0.0 to 6.0
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment PD	3 percentage of participants Interval 0.0 to 17.0	2 percentage of participants Interval 0.0 to 6.0
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment NE	0 percentage of participants Interval 0.0 to 11.0	0 percentage of participants Interval 0.0 to 3.0
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment Not Done	10 percentage of participants Interval 2.0 to 26.0	3 percentage of participants Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants with OR in the Full Analysis Set with available data were analyzed

DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=20 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=117 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Duration of Response (DOR) by Central Assessment	NA months Interval 8.2 to Data for median and upper limit of CI were not estimable due to low number of participants with events.	38.6 months Lower and upper limit of confidence intervals (CI) could not be estimated due to limited number of events and censoring. The Median was estimated because the longest observed participant event crossed 50%.

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants with OR in Full Analysis Set were analyzed.

DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6. KM estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=24 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=119 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
DOR by Investigator Assessment	NA months Interval 13.9 to Data for median and upper limit of CI was not estimable due to low number of participants with events.	60.4 months Interval 36.6 to Data for upper limit of CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 85.6 months

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

PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=29 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Progression-free Survival (PFS) Per Lugano Classification by Central Assessment	18.3 months Interval 12.1 to Data for median and upper limit of CI was not estimable due to low number of participants with events.	40.2 months Interval 28.9 to Data for upper limit of CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=31 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
PFS Per Lugano Classification by Investigator Assessment	NA months Interval 12.4 to Data for median and upper limit of CI was not estimable due to low number of participants with events.	58.2 months Interval 30.9 to Data for upper limit of CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 85.6

Population: Participants in the Full Analysis Set were analyzed.

OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=31 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Overall Survival (OS)	NA months Data for median, lower, and upper limits of CI were not estimable due to low number of participants with events	NA months Data for median, lower, and upper limits of CI were not estimable due to low number of participants with events

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Full Analysis Set were analyzed.

Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=31 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=127 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Time to Next Therapy	NA months Interval 12.1 to Data for median and upper limit of CI were not estimable due to low number of participants with events.	NA months Interval 37.8 to Data for median and upper limit of CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Safety Analysis Set were analyzed.

TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	100 percentage of participants	99 percentage of participants

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Safety Analysis Set were analyzed.

Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Alkaline Phosphatase (U/L)	4 percentage of participants	0 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L)	11 percentage of participants	4 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Bilirubin (umol/L)	11 percentage of participants	4 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Calcium (mmol/L)	0 percentage of participants	1 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Creatinine (umol/L)	0 percentage of participants	1 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Direct Bilirubin (umol/L)	11 percentage of participants	2 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Glucose (mmol/L)	21 percentage of participants	9 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Magnesium (mmol/L)	4 percentage of participants	3 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Potassium (mmol/L)	0 percentage of participants	1 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Sodium (mmol/L)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Urate (mmol/L)	25 percentage of participants	13 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Lymphocytes (10^9/L)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Alanine Aminotransferase (U/L)	21 percentage of participants	6 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Hemoglobin (mmol/L)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Increase in Leukocytes (10^9/L)	0 percentage of participants	1 percentage of participants

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants in the Safety Analysis Set were analyzed.

Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Hemoglobin (mmol/L)	39 percentage of participants	33 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Leukocytes (10^9/L)	93 percentage of participants	94 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Lymphocytes (10^9/L)	100 percentage of participants	99 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Neutrophils (10^9/L)	96 percentage of participants	92 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Platelets (10^9/L)	32 percentage of participants	35 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Albumin (g/L)	4 percentage of participants	2 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Calcium (mmol/L)	7 percentage of participants	10 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Glucose (mmol/L)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Magnesium (mmol/L)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Phosphate (mmol/L)	39 percentage of participants	23 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Potassium (mmol/L)	7 percentage of participants	4 percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher Grade 3 or Higher Decrease in Sodium (mmol/L)	18 percentage of participants	9 percentage of participants

SECONDARY outcome

Timeframe: Up to 85.6 months

Population: Participants from the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24

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

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Levels of Anti-CD19 CAR T Cells in Blood Day 7	120.07 cells/μL Standard Deviation 394.91	101.49 cells/μL Standard Deviation 220.01
Levels of Anti-CD19 CAR T Cells in Blood Week 2	90.76 cells/μL Standard Deviation 128.63	41.45 cells/μL Standard Deviation 63.65
Levels of Anti-CD19 CAR T Cells in Blood Week 4	14.03 cells/μL Standard Deviation 23.43	7.52 cells/μL Standard Deviation 19.85
Levels of Anti-CD19 CAR T Cells in Blood Month 18	0.42 cells/μL Standard Deviation 0.77	0.47 cells/μL Standard Deviation 1.51
Levels of Anti-CD19 CAR T Cells in Blood Month 24	0.88 cells/μL Standard Deviation 2.09	0.36 cells/μL Standard Deviation 0.84
Levels of Anti-CD19 CAR T Cells in Blood Month 3	0.52 cells/μL Standard Deviation 0.51	0.78 cells/μL Standard Deviation 1.91
Levels of Anti-CD19 CAR T Cells in Blood Month 6	0.68 cells/μL Standard Deviation 1.90	3.49 cells/μL Standard Deviation 28.89
Levels of Anti-CD19 CAR T Cells in Blood Month 12	0.23 cells/μL Standard Deviation 0.43	1.00 cells/μL Standard Deviation 5.65

SECONDARY outcome

Timeframe: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

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

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=123 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Baseline	19.87 mg/L Standard Deviation 28.62	22.36 mg/L Standard Deviation 40.60
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Day 0	32.94 mg/L Standard Deviation 42.50	29.30 mg/L Standard Deviation 47.35
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Day 3	66.73 mg/L Standard Deviation 92.82	72.50 mg/L Standard Deviation 91.76
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Day 7	77.79 mg/L Standard Deviation 91.86	59.45 mg/L Standard Deviation 79.24
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Week 2	13.59 mg/L Standard Deviation 42.20	9.07 mg/L Standard Deviation 19.70
Levels of Serum C-Reactive Protein (CRP) Serum CRP on Week 4	9.86 mg/L Standard Deviation 43.46	7.84 mg/L Standard Deviation 33.76

SECONDARY outcome

Timeframe: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

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

Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1).

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Day 3	792.47 ng/L Standard Deviation 621.84	964.45 ng/L Standard Deviation 904.79
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Day 3	4.71 ng/L Standard Deviation 13.53	3.87 ng/L Standard Deviation 3.36
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Day 7	1209.51 ng/L Standard Deviation 780.31	1224.58 ng/L Standard Deviation 1069.13
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Baseline	207.63 ng/L Standard Deviation 218.42	330.54 ng/L Standard Deviation 398.03
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Day 0	398.49 ng/L Standard Deviation 337.82	503.99 ng/L Standard Deviation 502.07
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Day 3	487.39 ng/L Standard Deviation 414.90	541.51 ng/L Standard Deviation 457.18
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Day 7	1820.38 ng/L Standard Deviation 4837.56	779.75 ng/L Standard Deviation 782.98
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Week 4	478.47 ng/L Standard Deviation 459.54	528.83 ng/L Standard Deviation 605.94
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Baseline	709.71 ng/L Standard Deviation 430.14	876.99 ng/L Standard Deviation 833.80
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Day 0	642.60 ng/L Standard Deviation 365.92	834.87 ng/L Standard Deviation 854.35
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Day 7	934.02 ng/L Standard Deviation 618.96	924.99 ng/L Standard Deviation 846.56
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Week 2	696.77 ng/L Standard Deviation 438.71	695.15 ng/L Standard Deviation 605.03
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum ICAM-1 on Week 4	614.92 ng/L Standard Deviation 487.67	671.32 ng/L Standard Deviation 656.46
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Baseline	5.62 ng/L Standard Deviation 7.50	8.52 ng/L Standard Deviation 12.15
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Day 0	4.91 ng/L Standard Deviation 4.12	8.39 ng/L Standard Deviation 9.10
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Day 3	7.31 ng/L Standard Deviation 5.68	9.96 ng/L Standard Deviation 11.53
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Day 7	19.78 ng/L Standard Deviation 20.82	14.42 ng/L Standard Deviation 15.10
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Week 2	10.40 ng/L Standard Deviation 12.26	7.16 ng/L Standard Deviation 8.27
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum IL-2 R alpha on Week 4	4.02 ng/L Standard Deviation 3.67	3.39 ng/L Standard Deviation 3.34
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Baseline	13.58 ng/L Standard Deviation 18.33	13.26 ng/L Standard Deviation 7.20
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Day 0	3.30 ng/L Standard Deviation 9.11	2.56 ng/L Standard Deviation 1.85
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Day 7	6.60 ng/L Standard Deviation 7.99	8.49 ng/L Standard Deviation 10.54
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Week 2	6.01 ng/L Standard Deviation 6.77	8.06 ng/L Standard Deviation 6.90
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Perforin on Week 4	12.32 ng/L Standard Deviation 12.08	14.56 ng/L Standard Deviation 11.92
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Baseline	1282.81 ng/L Standard Deviation 1232.76	1499.37 ng/L Standard Deviation 1637.98
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Day 0	931.58 ng/L Standard Deviation 709.94	1182.41 ng/L Standard Deviation 1166.58
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Day 3	1044.96 ng/L Standard Deviation 870.11	1213.84 ng/L Standard Deviation 962.38
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Week 2	977.88 ng/L Standard Deviation 919.47	891.64 ng/L Standard Deviation 726.10
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum VCAM-1 on Week 4	930.89 ng/L Standard Deviation 885.51	981.67 ng/L Standard Deviation 879.87
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 Serum Ferritin on Week 2	959.49 ng/L Standard Deviation 1546.07	741.76 ng/L Standard Deviation 787.70

SECONDARY outcome

Timeframe: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

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

Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel (Marginal Zone Lymphoma) n=28 Participants Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.	Axicabtagene Ciloleucel (Follicular Lymphoma) n=124 Participants Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Day 7	52.87 pg/mL Standard Deviation 68.63	76.29 pg/mL Standard Deviation 494.66
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Baseline	627.95 pg/mL Standard Deviation 467.39	584.66 pg/mL Standard Deviation 400.47
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Week 4	1106.94 pg/mL Standard Deviation 1935.55	653.88 pg/mL Standard Deviation 1197.23
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Baseline	1.12 pg/mL Standard Deviation 0.90	1.03 pg/mL Standard Deviation 0.53
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Week 4	58.84 pg/mL Standard Deviation 169.85	31.02 pg/mL Standard Deviation 122.14
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Week 4	3.03 pg/mL Standard Deviation 2.13	2.36 pg/mL Standard Deviation 1.65
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Baseline	634.56 pg/mL Standard Deviation 539.17	466.32 pg/mL Standard Deviation 339.00
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Day 0	763.99 pg/mL Standard Deviation 569.42	499.16 pg/mL Standard Deviation 334.85
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Day 3	962.96 pg/mL Standard Deviation 611.23	712.31 pg/mL Standard Deviation 543.76
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Day 7	1630.98 pg/mL Standard Deviation 563.40	841.62 pg/mL Standard Deviation 572.80
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Week 2	798.28 pg/mL Standard Deviation 631.80	474.45 pg/mL Standard Deviation 371.95
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum CXCL10 on Week 4	964.92 pg/mL Standard Deviation 640.57	623.87 pg/mL Standard Deviation 535.45
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Baseline	121.49 pg/mL Standard Deviation 623.76	3.58 pg/mL Standard Deviation 9.68
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Day 0	46.36 pg/mL Standard Deviation 234.23	2.95 pg/mL Standard Deviation 7.86
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Day 3	74.28 pg/mL Standard Deviation 348.53	6.53 pg/mL Standard Deviation 11.03
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Week 2	27.21 pg/mL Standard Deviation 102.65	2.73 pg/mL Standard Deviation 5.67
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum Granzyme B on Week 4	17.00 pg/mL Standard Deviation 39.90	3.14 pg/mL Standard Deviation 5.15
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Baseline	30.29 pg/mL Standard Deviation 83.67	9.25 pg/mL Standard Deviation 7.17
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Day 0	54.04 pg/mL Standard Deviation 140.40	11.20 pg/mL Standard Deviation 16.17
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Day 3	292.67 pg/mL Standard Deviation 531.54	157.13 pg/mL Standard Deviation 326.44
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Day 7	674.34 pg/mL Standard Deviation 792.31	139.82 pg/mL Standard Deviation 359.84
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Week 2	27.16 pg/mL Standard Deviation 37.43	25.98 pg/mL Standard Deviation 48.82
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IFN-gamma on Week 4	56.72 pg/mL Standard Deviation 108.10	23.96 pg/mL Standard Deviation 37.04
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Day 0	960.41 pg/mL Standard Deviation 1342.30	677.50 pg/mL Standard Deviation 743.22
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Day 3	848.20 pg/mL Standard Deviation 757.98	703.79 pg/mL Standard Deviation 772.95
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Day 7	2492.85 pg/mL Standard Deviation 2895.93	1125.80 pg/mL Standard Deviation 1316.88
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-1 RA on Week 2	854.68 pg/mL Standard Deviation 1693.69	591.72 pg/mL Standard Deviation 764.19
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Day 0	1.16 pg/mL Standard Deviation 1.09	1.20 pg/mL Standard Deviation 1.22
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Day 3	12.43 pg/mL Standard Deviation 34.49	8.01 pg/mL Standard Deviation 13.08
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Day 7	2.99 pg/mL Standard Deviation 3.78	1.67 pg/mL Standard Deviation 2.55
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Week 2	0.93 pg/mL Standard Deviation 0.18	0.95 pg/mL Standard Deviation 0.48
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-2 on Week 4	1.10 pg/mL Standard Deviation 1.06	0.95 pg/mL Standard Deviation 0.50
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Baseline	5.08 pg/mL Standard Deviation 8.11	2.71 pg/mL Standard Deviation 2.90
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Day 0	4.14 pg/mL Standard Deviation 5.39	2.42 pg/mL Standard Deviation 2.27
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Day 3	103.93 pg/mL Standard Deviation 281.61	59.30 pg/mL Standard Deviation 185.89
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Day 7	206.75 pg/mL Standard Deviation 282.31	67.49 pg/mL Standard Deviation 197.95
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-6 on Week 2	33.00 pg/mL Standard Deviation 66.24	20.01 pg/mL Standard Deviation 92.15
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Baseline	15.30 pg/mL Standard Deviation 7.13	15.99 pg/mL Standard Deviation 7.89
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Day 0	28.31 pg/mL Standard Deviation 10.15	27.65 pg/mL Standard Deviation 9.62
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Day 3	27.24 pg/mL Standard Deviation 10.82	26.50 pg/mL Standard Deviation 10.22
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Day 7	23.28 pg/mL Standard Deviation 11.69	23.42 pg/mL Standard Deviation 11.28
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Week 2	26.38 pg/mL Standard Deviation 16.52	27.25 pg/mL Standard Deviation 14.13
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-7 on Week 4	20.30 pg/mL Standard Deviation 10.52	18.45 pg/mL Standard Deviation 8.92
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Baseline	13.71 pg/mL Standard Deviation 9.11	13.59 pg/mL Standard Deviation 15.09
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Day 0	42.71 pg/mL Standard Deviation 129.39	21.12 pg/mL Standard Deviation 33.53
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Day 3	80.86 pg/mL Standard Deviation 154.41	60.27 pg/mL Standard Deviation 126.84
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Day 7	37.47 pg/mL Standard Deviation 30.74	45.79 pg/mL Standard Deviation 86.38
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Week 2	41.41 pg/mL Standard Deviation 117.98	16.08 pg/mL Standard Deviation 17.14
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-8 on Week 4	18.90 pg/mL Standard Deviation 13.80	20.36 pg/mL Standard Deviation 68.72
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Baseline	5.11 pg/mL Standard Deviation 6.72	2.85 pg/mL Standard Deviation 3.76
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Day 0	1.89 pg/mL Standard Deviation 2.18	1.93 pg/mL Standard Deviation 2.29
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Day 3	7.39 pg/mL Standard Deviation 10.14	9.34 pg/mL Standard Deviation 17.60
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Day 7	20.32 pg/mL Standard Deviation 20.70	15.01 pg/mL Standard Deviation 34.55
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Week 2	3.42 pg/mL Standard Deviation 4.88	2.06 pg/mL Standard Deviation 4.64
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-10 on Week 4	1.65 pg/mL Standard Deviation 2.08	1.10 pg/mL Standard Deviation 1.31
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Baseline	2.59 pg/mL Standard Deviation 1.42	2.70 pg/mL Standard Deviation 2.69
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Day 0	33.89 pg/mL Standard Deviation 16.32	31.06 pg/mL Standard Deviation 13.55
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Day 3	43.43 pg/mL Standard Deviation 37.40	35.27 pg/mL Standard Deviation 19.66
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Day 7	25.22 pg/mL Standard Deviation 15.38	18.73 pg/mL Standard Deviation 9.77
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Week 2	12.92 pg/mL Standard Deviation 8.28	10.30 pg/mL Standard Deviation 5.90
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum IL-15 on Week 4	7.41 pg/mL Standard Deviation 5.21	4.98 pg/mL Standard Deviation 3.52
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Baseline	6.73 pg/mL Standard Deviation 7.86	7.26 pg/mL Standard Deviation 7.87
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Day 0	3.08 pg/mL Standard Deviation 1.68	3.32 pg/mL Standard Deviation 2.62
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Day 3	4.90 pg/mL Standard Deviation 4.59	3.95 pg/mL Standard Deviation 2.68
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Day 7	5.97 pg/mL Standard Deviation 4.09	3.93 pg/mL Standard Deviation 3.10
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha Serum TNF Alpha on Week 2	2.74 pg/mL Standard Deviation 2.30	2.84 pg/mL Standard Deviation 6.01

Adverse Events

Axicabtagene Ciloleucel: Follicular Lymphoma

Serious events: 65 serious events

Other events: 123 other events

Deaths: 36 deaths

Axicabtagene Ciloleucel: Marginal Zone Lymphoma

Serious events: 19 serious events

Other events: 28 other events

Deaths: 8 deaths

Axicabtagene Ciloleucel: Retreatment (FL)

Serious events: 5 serious events

Other events: 13 other events

Deaths: 5 deaths

Axicabtagene Ciloleucel: Retreatment (MZL)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Information

Kite, A Gilead Company

Phone: 844-454-5483 (1-844-454-KITE)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER