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Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ZUMA-8)

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ClinicalTrials.gov Identifier: NCT03624036
Recruitment Status : Terminated (Development program terminated)
First Posted : August 9, 2018
Results First Posted : May 10, 2022
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma
Interventions Biological: brexucabtagene autoleucel
Drug: Fludarabine
Drug: Cyclophosphamide
Enrollment 16
Recruitment Details Participants were enrolled at study sites in the United States and Italy. The study was terminated before enrolling participants in the Cohort 4B.
Pre-assignment Details 17 participants were screened.
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 7 3 3 3
Completed 0 0 0 0
Not Completed 7 3 3 3
Reason Not Completed
Death             2             3             0             1
Withdrawal by Subject             1             0             1             0
Enrolled but Never Treated             1             0             0             0
Reason not Specified             3             0             2             2
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 3 3 3 15
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
3
 100.0%
1
  33.3%
1
  33.3%
9
  60.0%
>=65 years
2
  33.3%
0
   0.0%
2
  66.7%
2
  66.7%
6
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
60.8  (5.8) 58.7  (5.9) 68.0  (11.5) 63.3  (9.1) 62.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
Female
3
  50.0%
1
  33.3%
0
   0.0%
1
  33.3%
5
  33.3%
Male
3
  50.0%
2
  66.7%
3
 100.0%
2
  66.7%
10
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
15
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
0
   0.0%
1
  33.3%
2
  13.3%
White
5
  83.3%
3
 100.0%
3
 100.0%
2
  66.7%
13
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 6 participants 3 participants 3 participants 3 participants 15 participants
United States
6
 100.0%
2
  66.7%
3
 100.0%
3
 100.0%
14
  93.3%
Italy
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   6.7%
1.Primary Outcome
Title Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
DLT Evaluable Set included all participants treated with the target brexucabtagene autoleucel dose and followed for at least 28 days.
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 3 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
2.Secondary Outcome
Title Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria
Hide Description 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.
Time Frame First infusion date up to last follow up visit (maximum duration: 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Set included all participants who were treated with any dose of brexucabtagene autoleucel.
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 3 3 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50
(11.8 to 88.2)
33
(0.8 to 90.6)
100
(29.2 to 100.0)
0
(0.0 to 70.8)
3.Secondary Outcome
Title Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame First infusion date up to last follow up visit (maximum duration: 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 3 3 3
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100
4.Secondary Outcome
Title Peak Level of Anti-CD19 CAR T-Cells in Blood
Hide Description Peak was defined as the maximum number of CAR T cells measured post-infusion.
Time Frame First infusion date up to 3 months post-infusion (approximately 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety analysis set with available data were analyzed.
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 2 3 3
Median (Inter-Quartile Range)
Unit of Measure: cells/μL
1.46
(0.58 to 2.35)
1.08
(0.00 to 2.15)
42.18
(27.52 to 679.38)
1.00
(0.00 to 1.27)
Time Frame All-Cause Mortality: Enrollment up to last follow up visit (maximum: 43 months); Adverse Events: First infusion date up to last follow up visit (maximum: 42 months)
Adverse Event Reporting Description

All-Cause Mortality: All Enrolled Analysis Set included all the enrolled participants.

Adverse Events: Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.
 
Arm/Group Title First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)   3/3 (100.00%)   0/3 (0.00%)   1/3 (33.33%) 
Hide Serious Adverse Events
First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   2/3 (66.67%)   3/3 (100.00%)   1/3 (33.33%) 
Cardiac disorders         
Tachycardia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
General disorders         
Chills † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Malaise † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Pyrexia † 1  1/6 (16.67%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations         
Cellulitis † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Pneumonia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Rhinovirus infection † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Sepsis † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Systemic candida † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders         
Failure to thrive † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Chronic lymphocytic leukaemia † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Aphasia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Psychiatric disorders         
Confusional state † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vascular disorders         
Embolism † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypotension † 1  0/6 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA (25.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders         
Anaemia † 1  2/6 (33.33%)  2/3 (66.67%)  1/3 (33.33%)  2/3 (66.67%) 
Leukopenia † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Lymphadenopathy † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Neutropenia † 1  4/6 (66.67%)  3/3 (100.00%)  0/3 (0.00%)  2/3 (66.67%) 
Pancytopenia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Thrombocytopenia † 1  2/6 (33.33%)  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%) 
Cardiac disorders         
Pericardial effusion † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Sinus bradycardia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Sinus tachycardia † 1  2/6 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Tachycardia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Eye disorders         
Dry eye † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Retinal tear † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vitreous floaters † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Abdominal pain † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Constipation † 1  2/6 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%) 
Diarrhoea † 1  2/6 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%) 
Dry mouth † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Nausea † 1  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Odynophagia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
General disorders         
Catheter site pain † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Chills † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Fatigue † 1  3/6 (50.00%)  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%) 
Influenza like illness † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Malaise † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema peripheral † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pain † 1  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pyrexia † 1  4/6 (66.67%)  1/3 (33.33%)  3/3 (100.00%)  2/3 (66.67%) 
Hepatobiliary disorders         
Hepatotoxicity † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations         
Candida infection † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Covid-19 † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Cytomegalovirus viraemia † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Folliculitis † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Oral candidiasis † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pneumonia † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Pneumonia aspiration † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Rhinovirus infection † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications         
Fall † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Investigations         
Alanine aminotransferase increased † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Aspartate aminotransferase increased † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood alkaline phosphatase increased † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood bicarbonate decreased † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Blood bilirubin increased † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood creatinine increased † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Blood lactate dehydrogenase increased † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
C-reactive protein increased † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Electrocardiogram QT prolonged † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Lymphocyte count decreased † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Lymphocyte count increased † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Neutrophil count decreased † 1  1/6 (16.67%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%) 
Platelet count decreased † 1  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%) 
White blood cell count decreased † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Metabolism and nutrition disorders         
Decreased appetite † 1  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Hyperglycaemia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hypermagnesaemia † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hypervolaemia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoalbuminaemia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypocalcaemia † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hypokalaemia † 1  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Hypomagnesaemia † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hyponatraemia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hypophosphataemia † 1  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Bone pain † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Muscular weakness † 1  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal pain † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Nervous system disorders         
Amnesia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Aphasia † 1  1/6 (16.67%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Ataxia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cognitive disorder † 1  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Dizziness † 1  2/6 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Dysgeusia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Dysgraphia † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Encephalopathy † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Headache † 1  5/6 (83.33%)  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%) 
Lethargy † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Nystagmus † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Somnolence † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Taste disorder † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Transient ischaemic attack † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Tremor † 1  2/6 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Psychiatric disorders         
Anxiety † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Confusional state † 1  2/6 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Delirium † 1  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Frustration tolerance decreased † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Hallucination † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Insomnia † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Renal and urinary disorders         
Acute kidney injury † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pollakiuria † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Urinary incontinence † 1  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders         
Pruritus genital † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  2/6 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Dysphonia † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Dyspnoea † 1  0/6 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%) 
Epistaxis † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hiccups † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoxia † 1  1/6 (16.67%)  1/3 (33.33%)  2/3 (66.67%)  0/3 (0.00%) 
Tachypnoea † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Night sweats † 1  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Petechiae † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pruritus † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Rash † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Rash maculo-papular † 1  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Rash pruritic † 1  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vascular disorders         
Hypertension † 1  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hypotension † 1  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
1
Term from vocabulary, MedDRA (25.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Kite, A Gilead Company
Phone: 844-454-5483 (1-844-454-KITE)
EMail: medinfo@kitepharma.com
Publications of Results:
Davids MS, Kenderian SS, Flinn IW, Hill BT, Maris M, Ghia P, et al. ZUMA-8: A Phase 1 Study of KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia. Blood. 2022;140:7454-6.
Layout table for additonal information
Responsible Party: Gilead Sciences ( Kite, A Gilead Company )
ClinicalTrials.gov Identifier: NCT03624036    
Other Study ID Numbers: KTE-C19-108
2018-001923-38 ( EudraCT Number )
First Submitted: August 7, 2018
First Posted: August 9, 2018
Results First Submitted: February 14, 2022
Results First Posted: May 10, 2022
Last Update Posted: November 18, 2023