Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (NCT NCT03624036)

Last Updated: 2023-11-18

Results Overview

DLTs refer to toxicities with onset experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLTs evaluated may include with some exceptions: All brexucabtagene autoleucel related Grade 3 non-hematologic toxicities lasting for more than 7 days, Grade 4 non-hematologic toxicities regardless of duration, and Grade 4 hematologic toxicity lasting more than 30 days if not attributable to underlying disease.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but Grade 4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation.

Results posted on

2023-11-18

Participant Flow

Participants were enrolled at study sites in the United States and Italy. The study was terminated before enrolling participants in the Cohort 4B.

17 participants were screened.

Participant milestones

Participant milestones
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered intravenously (IV) on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL and small lymphocytic lymphoma (SLL) with ≤1% malignant cells in peripheral blood or absolute lymphocyte count (ALC) \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, B-cell lymphoma 2 (BCL-2) and Phosphoinositide 3-kinase (PI3k) inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
Overall Study STARTED	7	3	3	3
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	7	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered intravenously (IV) on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL and small lymphocytic lymphoma (SLL) with ≤1% malignant cells in peripheral blood or absolute lymphocyte count (ALC) \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, B-cell lymphoma 2 (BCL-2) and Phosphoinositide 3-kinase (PI3k) inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
Overall Study Death	2	3	0	1
Overall Study Withdrawal by Subject	1	0	1	0
Overall Study Enrolled but Never Treated	1	0	0	0
Overall Study Reason not Specified	3	0	2	2

Baseline Characteristics

Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=6 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Total n=15 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	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Age, Continuous	60.8 years STANDARD_DEVIATION 5.8 • n=5 Participants	58.7 years STANDARD_DEVIATION 5.9 • n=7 Participants	68.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	63.3 years STANDARD_DEVIATION 9.1 • n=4 Participants	62.3 years STANDARD_DEVIATION 7.7 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	6 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Italy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but Grade 4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation.

Population: DLT Evaluable Set included all participants treated with the target brexucabtagene autoleucel dose and followed for at least 28 days.

Outcome measures

Outcome measures
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=6 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
Number of Participants Experiencing Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: First infusion date up to last follow up visit (maximum duration: 42 months)

Population: All Treated Subjects Set included all participants who were treated with any dose of brexucabtagene autoleucel.

ORR was defined as percentage of participants achieving either complete response (CR), complete response with incomplete hematopoetic recovery (CRi) or partial response (PR). Criteria for CR: no lymphadenopathy \>1.5 cm or hepatomegaly/splenomegaly, lymphocytes \<4000/microliters (μL), bone marrow sample must be normocellular with 30% lymphocytes and no B-lymphoid nodules, platelets ≥100,000/µL, hemoglobin ≥11 grams per deciliter (g/dL). CRi: All CR criteria were met except with platelet count \<100,000/μL, hemoglobin \<11 g/dL or neutrophil count \<500/μL. PR: ≥1 of these: ≥50% decrease in lymphocytes, lymphadenopathy, size of liver and spleen, 50% decrease in bone marrow infiltrates; and ≥1 of these: platelets ≥100,000/µL or ≥50% increase from Baseline, hemoglobin ≥11 g/dL or ≥50% increase from Baseline. Participants who did not meet criteria were considered nonresponders. 95% confidence interval (CI) was calculated by Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=6 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria	50 percentage of participants Interval 11.8 to 88.2	33 percentage of participants Interval 0.8 to 90.6	100 percentage of participants Interval 29.2 to 100.0	0 percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: First infusion date up to last follow up visit (maximum duration: 42 months)

Population: Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.

An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs were defined as AEs with onset on or after the initiation of brexucabtagene autoleucel infusion.

Outcome measures

Outcome measures
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=6 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
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: First infusion date up to 3 months post-infusion (approximately 3 months)

Population: Participants in the safety analysis set with available data were analyzed.

Peak was defined as the maximum number of CAR T cells measured post-infusion.

Outcome measures

Outcome measures
Measure	First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=6 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg n=2 Participants Participants with r/r CLL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL and SLL with ≤1% malignant cells in peripheral blood or ALC \< 5,000 cells/μL received conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.	Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg n=3 Participants Participants with r/r CLL who previously received two lines of therapy along with ibrutinib with or without anti CD20 antibodies, BCL-2 and PI3k inhibitors received ibrutinib up to 30 hours prior to leukapheresis along with conditioning chemotherapy (fludarabine 30 mg/m\^2/day over 30 minutes and cyclophosphamide 500 mg/m\^2/day over 30-60 minutes) administered IV on Days -5 to -3 with 2 rest days, followed by single infusion of brexucabtagene autoleucel 1 x 10\^6 anti-CD19 CAR T cells/kg administered IV on Day 0.
Peak Level of Anti-CD19 CAR T-Cells in Blood	1.46 cells/μL Interval 0.58 to 2.35	1.08 cells/μL Interval 0.0 to 2.15	42.18 cells/μL Interval 27.52 to 679.38	1.00 cells/μL Interval 0.0 to 1.27

Adverse Events

First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 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