Trial Outcomes & Findings for Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT02926833)

Last Updated: 2024-03-06

Results Overview

A DLT was defined as the following KTE-C19-related or ATZ-related events with an onset from immediately after the first ATZ infusion through 21 days after the first ATZ infusion: Grade 4 hematologic toxicity lasting \> 30 days (except lymphopenia or B-cell aplasia); All KTE-C19- or ATZ-related Grade 3 non-hematologic toxicities lasting for \> 7 days and all KTE-C19- or ATZ-related Grade 4 non-hematologic toxicities regardless of duration.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Baseline up to 21 days

Results posted on

2024-03-06

Participant Flow

Participants were enrolled at study sites in the United States.

44 participants were screened.

Participant milestones

Participant milestones
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Overall Study STARTED	3	4	7	23
Overall Study COMPLETED	1	0	1	0
Overall Study NOT COMPLETED	2	4	6	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Overall Study Death	1	1	2	13
Overall Study Lost to Follow-up	1	2	0	3
Overall Study Full Consent Withdrawal	0	0	0	2
Overall Study Rolled Over to Long-term Follow-up Study	0	0	3	4
Overall Study Investigator Decision	0	1	0	0
Overall Study Adverse Event	0	0	1	0
Overall Study Partial Withdrawal of Consent	0	0	0	1

Baseline Characteristics

Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants	28 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Age, Continuous	56.0 years STANDARD_DEVIATION 14.80 • n=5 Participants	42.7 years STANDARD_DEVIATION 19.50 • n=7 Participants	53.2 years STANDARD_DEVIATION 6.18 • n=5 Participants	58.4 years STANDARD_DEVIATION 7.40 • n=4 Participants	56 years STANDARD_DEVIATION 9.9 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants	28 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants	34 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to 21 days

Population: DLT Evaluable Set included all participants in Phase 1 treated with KTE-C19 and at least 1 dose of ATZ who either received target KTE-C19 dose and followed for at least 21 days after first ATZ infusion; or received a dose of KTE-C19 lower than target for that cohort and a subsequent ATZ infusion and experienced a DLT.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years)

Population: The Modified Intent-to-Treat Analysis (mITT) Set included all participants enrolled in Phase 1 Cohort 3 and Phase 2 and treated with target dose of KTE-C19 and at least one dose of atezolizumab.

CRR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Complete Response Rate (CRR)	54 percentage of participants Interval 34.0 to 72.0	—	—	—

SECONDARY outcome

Timeframe: From enrollment until first occurrence of CR or PR (maximum duration: 6.2 years)

Population: Participants in the mITT Analysis Set were analyzed.

ORR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a CR or partial response (PR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Participants who did not meet the criteria for objective response by the analysis cutoff date were considered non-responders.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Objective Response Rate (ORR)	75 percentage of participants Interval 55.0 to 89.0	—	—	—

SECONDARY outcome

Timeframe: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (maximum duration: 6.2 years)

Population: Participants in the mITT Analysis Set with objective response were analyzed.

DOR for participants who experienced an objective response was defined as the date of their first confirmed objective response (CR or PR) to disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death regardless of cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate DOR.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=21 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Duration of Response (DOR)	41.4 months Interval 1.8 to Due to less number of participants with an event, upper limit of 95% confidence interval (CI) was not estimable.	—	—	—

SECONDARY outcome

Timeframe: From the date of first KTE-C19 infusion to disease progression or death regardless of cause (maximum duration: 6.2 years)

Population: Participants in the mITT Analysis Set were analyzed.

PFS was defined as the time from the KTE-C19 infusion date to the date of disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death from any cause. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate PFS.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Progression-Free Survival (PFS)	9 months Interval 3.1 to Due to less number of participants with an event, upper limit of 95% CI was not estimable.	—	—	—

SECONDARY outcome

Timeframe: From the date of first KTE-C19 infusion to the date of death regardless of cause (maximum duration: 6.2 years)

Population: Participants in the mITT Analysis Set were analyzed.

OS was defined as the time from KTE-C19 infusion to the date of death from any cause. The Kaplan-Meier approach was used to estimate OS.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Overall Survival (OS)	32.2 months Interval 11.6 to Due to less number of participants with an event, upper limit of 95% CI were not estimable.	—	—	—

SECONDARY outcome

Timeframe: Up to 1.8 years

Population: The Safety Analysis Set was defined as all participants treated with any dose of KTE-C19.

An adverse event was defined as any untoward medical occurrence in a clinical trial participant. The event did not necessarily have a relationship with study treatment. Adverse events 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 in study, was not considered an adverse event. TEAEs included all AEs with onset on or after initiation of axicabtagene ciloleucel.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 1.8 years

Population: Participants in the Safety Analysis Set were analyzed.

Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date. ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 4 AST	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 bilirubin	0 percentage of participants	0 percentage of participants	0 percentage of participants	9 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 4 calcium	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 creatinine	0 percentage of participants	0 percentage of participants	0 percentage of participants	9 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 4 creatinine	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 direct bilirubin	33 percentage of participants	33 percentage of participants	17 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 glucose	0 percentage of participants	0 percentage of participants	0 percentage of participants	18 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 4 glucose	0 percentage of participants	0 percentage of participants	0 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 ALT	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 4 ALT	0 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 ALP	0 percentage of participants	0 percentage of participants	0 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values Shift to Grade 3 AST	0 percentage of participants	0 percentage of participants	0 percentage of participants	9 percentage of participants

SECONDARY outcome

Timeframe: Up to 1.8 years

Population: Participants in the Safety Analysis Set were analyzed.

Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 albumin	33 percentage of participants	0 percentage of participants	0 percentage of participants	9 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 calcium	33 percentage of participants	0 percentage of participants	0 percentage of participants	5 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 calcium	0 percentage of participants	0 percentage of participants	0 percentage of participants	18 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 phosphate	67 percentage of participants	67 percentage of participants	33 percentage of participants	36 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 phosphate	0 percentage of participants	0 percentage of participants	0 percentage of participants	36 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 potassium	0 percentage of participants	0 percentage of participants	0 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 sodium	67 percentage of participants	0 percentage of participants	17 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 glucose	0 percentage of participants	0 percentage of participants	17 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 1.8 years

Population: Participants in the Safety Analysis Set were analyzed.

Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 1.8 years

Population: Participants in the Safety Analysis Set were analyzed.

Post axicabtagene ciloleucel infusion lab toxicities were reported. It included lab toxicities observed on or after the axicabtagene ciloleucel infusion date.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 hemoglobin	100 percentage of participants	67 percentage of participants	83 percentage of participants	59 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 leukocytes	0 percentage of participants	0 percentage of participants	33 percentage of participants	18 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 leukocytes	100 percentage of participants	100 percentage of participants	67 percentage of participants	77 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 lymphocytes	100 percentage of participants	100 percentage of participants	100 percentage of participants	86 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 neutrophils	0 percentage of participants	33 percentage of participants	17 percentage of participants	14 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 neutrophils	100 percentage of participants	67 percentage of participants	83 percentage of participants	73 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 3 platelets	33 percentage of participants	0 percentage of participants	17 percentage of participants	18 percentage of participants
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values Shift to Grade 4 platelets	33 percentage of participants	67 percentage of participants	17 percentage of participants	32 percentage of participants

SECONDARY outcome

Timeframe: Pre-infusion (Baseline); Post-infusion: Days 7 (Phase 2), 14, 22 (Phase 2), 28 (Phase 2; optional), 35 (Phase 1, Cohort 3; optional), 43, 49 (optional), 64, 69 (optional), 94; long-term follow-up: every 3 months from Month 6 to Month 18, and Month 24

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood	86.87 cells/μL Standard Deviation 67.17	167.88 cells/μL Standard Deviation 91.58	60.71 cells/μL Standard Deviation 70.66	60.22 cells/μL Standard Deviation 60.24

SECONDARY outcome

Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174

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

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Atezolizumab Levels in Blood Day 64	—	—	159000 ng/mL Standard Deviation 91600	185000 ng/mL Standard Deviation 88700
Phase 1 and 2: Atezolizumab Levels in Blood Day 1	—	—	373000 ng/mL Standard Deviation 65300	328000 ng/mL Standard Deviation 89100
Phase 1 and 2: Atezolizumab Levels in Blood Day 14	—	435000 ng/mL Standard Deviation 61500	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 21	403000 ng/mL Standard Deviation 46100	—	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 22	—	—	73900 ng/mL Standard Deviation 27900	110000 ng/mL Standard Deviation 126000
Phase 1 and 2: Atezolizumab Levels in Blood Day 35	—	84200 ng/mL Standard Deviation 14300	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 42	98800 ng/mL Standard Deviation 16500	—	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 43	—	—	138000 ng/mL Standard Deviation 78700	136000 ng/mL Standard Deviation 69900
Phase 1 and 2: Atezolizumab Levels in Blood Day 56	—	176000 ng/mL Standard Deviation 2828.43	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 63	175000 ng/mL Standard Deviation 7505.55	—	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 77	—	240000 ng/mL Standard Deviation 33000	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 84	209000 ng/mL Standard Deviation 24800	—	—	—
Phase 1 and 2: Atezolizumab Levels in Blood Day 154	—	—	13600 ng/mL	66800 ng/mL Standard Deviation 58900
Phase 1 and 2: Atezolizumab Levels in Blood Day 174	91000 ng/mL	—	—	—

SECONDARY outcome

Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, 14, 22 , 28, Day 35, 49, 69, and 94 post-KTE-C19 infusion

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) n=3 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) n=6 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) n=22 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion

Population: Participants in the mITT Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood	174.03 mg/L Interval 51.78 to 496.0	—	—	—

SECONDARY outcome

Population: Participants in the mITT Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IL-6	121.55 pg/mL Interval 4.3 to 976.0	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IL-8	180.65 pg/mL Interval 18.6 to 750.0	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood CXCL 10	2000.00 pg/mL Interval 444.8 to 2000.0	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IFN-γ	587.80 pg/mL Interval 15.6 to 1876.0	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IL-1RA	2469.60 pg/mL Interval 541.4 to 9000.0	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IL-2	17.55 pg/mL Interval 1.8 to 152.7	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood IL-15	48.95 pg/mL Interval 19.1 to 161.2	—	—	—
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood TNF-α	8.20 pg/mL Interval 3.4 to 55.5	—	—	—

SECONDARY outcome

Population: Participants in the mITT Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Peak Serum Levels of Ferritin in Blood	1427.39 ng/mL Interval 219.92 to 23100.0	—	—	—

SECONDARY outcome

Population: Participants in the mITT Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) n=28 Participants Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.	Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.	Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.	Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood	17.75 ng/mL Interval 3.45 to 57.77	—	—	—

Adverse Events

Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)

Serious events: 15 serious events

Other events: 22 other events

Deaths: 14 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