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CAR T-cell Therapy

Second Stage Cohort 4B: 2 x 10^6 Anti-CD19 CAR T Cells/kg for Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (ZUMA-8 Trial)

Phase 1
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first infusion date up to last follow up visit (maximum duration: 42 months)
Awards & highlights

ZUMA-8 Trial Summary

This study is evaluating whether a new drug called KTE-X19 is safe and tolerable in people with chronic lymphocytic leukemia.

Eligible Conditions
  • Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

ZUMA-8 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first infusion date up to last follow up visit (maximum duration: 42 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date up to last follow up visit (maximum duration: 42 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria
Peak Level of Anti-CD19 CAR T-Cells in Blood
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

ZUMA-8 Trial Design

5Treatment groups
Experimental Treatment
Group I: Second Stage Cohort 4B: 2 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
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 will receive 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) 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 on Day 0. Upon completion of Cohort 4A, it was determined not to enroll participants in Cohort 4B.
Group II: Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
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 will receive 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) 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 on Day 0.
Group III: Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
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 will receive conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) 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 on Day 0.
Group IV: First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with r/r CLL will receive conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) 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 on Day 0.
Group V: First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL) will receive conditioning chemotherapy (fludarabine 30 mg/m^2/day over 30 minutes and cyclophosphamide 500 mg/m^2/day over 30-60 minutes) 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 on Day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brexucabtagene autoleucel
2016
Completed Phase 2
~230
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,640 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,677 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,998 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
2018. "Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03624036.
~2 spots leftby Apr 2025
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