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CAR T-cell Therapy

Combination Therapy for B-Precursor Acute Lymphoblastic Leukemia (ZUMA-3 Trial)

Phase 1 & 2
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 of brexucabtagene autoleucel (phase 2) to data cutoff date of 09 september 2020 (maximum duration: 23 months)
Awards & highlights

ZUMA-3 Trial Summary

This trial is testing a new drug, KTE-X19, to see if it is safe and effective for people with a certain type of leukemia that has come back or does not respond to treatment.

Eligible Conditions
  • Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

ZUMA-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first cr or cri (phase 2) to relapse/death or data cutoff date of 09 september 2020 (maximum duration: 23 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first cr or cri (phase 2) to relapse/death or data cutoff date of 09 september 2020 (maximum duration: 23 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
Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review
Secondary outcome measures
Phase 2: Change From Baseline Over Time in EQ-5D: Visual Analogue Scale (VAS)
Phase 2: Complete Remission (CR) Rate Per Independent Review
Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review
+13 more

ZUMA-3 Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered.
Group II: Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) will receive conditioning chemotherapy (fludarabine 25 mg/m^2 intravenously [IV] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered.
Group III: Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered.
Group IV: Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kgExperimental Treatment3 Interventions
Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
brexucabtagene autoleucel
2016
Completed Phase 2
~230
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,531 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,889 Total Patients Enrolled

Media Library

Brexucabtagene Autoleucel (KTE-X19) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02614066 — Phase 1 & 2
B-Precursor Acute Lymphoblastic Leukemia Research Study Groups: Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg, Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg, Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg, Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
B-Precursor Acute Lymphoblastic Leukemia Clinical Trial 2023: Brexucabtagene Autoleucel (KTE-X19) Highlights & Side Effects. Trial Name: NCT02614066 — Phase 1 & 2
Brexucabtagene Autoleucel (KTE-X19) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02614066 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas is this evaluation being conducted?

"Patients are currently being enlisted at the University of California Irvine Medical Center in Orange, CA, Emory University located in Atlanta, GA and Toronto's Princess Margaret Hospital. Furthermore, 24 other medical centers across America have opened enrolment for this trial."

Answered by AI

Is this trial currently taking on new participants?

"Contrary to expectations, clinicaltrials.gov has revealed that this study is no longer accepting participants. It was first announced on the 7th of March 2016 and its latest update was posted on 21st September 2022. Fortunately, 2385 other trials are still welcoming applicants at present."

Answered by AI

Has brexucabtagene autoleucel been the subject of any past research endeavors?

"Brexucabtagene autoleucel was first studied in 1997 at the City of Hope Comprehensive Cancer Center and has since seen 1275 completed trials. In the present, 890 live clinical trials are underway, with many taking place out of Orange, California."

Answered by AI

What is the principal use of brexucabtagene autoleucel?

"Brexucabtagene autoleucel has the potential to treat multiple sclerosis, as well as acute lymphoblastic leukemia, myelocytic leukemia, refractory b-cell precursor acute lymphoblastic leukaemia, and retinoblastoma."

Answered by AI

How many participants are currently involved in this research project?

"This clinical trial has already filled its quota and is no longer accepting patients. Initially posted on March 7th 2016, the study was most recently edited on September 21st 2022. For those looking for alternative trials, there are currently 1,495 studies actively seeking participants with leukemia lymphocytic acute l1 and 890 studies searching for brexucabtagene autoleucel volunteers."

Answered by AI
Recent research and studies
The LancetJournal
KTE-X19 for Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukaemia: Phase 2 Results of the Single-arm, Open-label, Multicentre ZUMA-3 Study
Shah, Bijal D, Armin Ghobadi, Olalekan O Oluwole, Aaron C Logan, Nicolas Boissel, Ryan D Cassaday, Thibaut Leguay, et al.. 2021. “KTE-X19 for Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukaemia: Phase 2 Results of the Single-arm, Open-label, Multicentre ZUMA-3 Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)01222-8.
BloodJournal
KTE-X19 Anti-cd19 CAR T-cell Therapy in Adult Relapsed/refractory Acute Lymphoblastic Leukemia: ZUMA-3 Phase 1 Results
Shah, Bijal D., Michael R. Bishop, Olalekan O. Oluwole, Aaron C. Logan, Maria R. Baer, William B. Donnellan, Kristen M. O’Dwyer, et al.. 2021. “KTE-X19 Anti-cd19 CAR T-cell Therapy in Adult Relapsed/refractory Acute Lymphoblastic Leukemia: ZUMA-3 Phase 1 Results”. Blood. American Society of Hematology. doi:10.1182/blood.2020009098.
BloodJournal
KTE-X19 Anti-cd19 CAR T-cell Therapy in Adult Relapsed/refractory Acute Lymphoblastic Leukemia: ZUMA-3 Phase 1 Results
Shah, Bijal D., Michael R. Bishop, Olalekan O. Oluwole, Aaron C. Logan, Maria R. Baer, William B. Donnellan, Kristen M. O’Dwyer, et al.. 2021. “KTE-X19 Anti-cd19 CAR T-cell Therapy in Adult Relapsed/refractory Acute Lymphoblastic Leukemia: ZUMA-3 Phase 1 Results”. Blood. American Society of Hematology. doi:10.1182/blood.2020009098.
The LancetJournal
KTE-X19 for Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukaemia: Phase 2 Results of the Single-arm, Open-label, Multicentre ZUMA-3 Study
Shah, Bijal D, Armin Ghobadi, Olalekan O Oluwole, Aaron C Logan, Nicolas Boissel, Ryan D Cassaday, Thibaut Leguay, et al.. 2021. “KTE-X19 for Relapsed or Refractory Adult B-cell Acute Lymphoblastic Leukaemia: Phase 2 Results of the Single-arm, Open-label, Multicentre ZUMA-3 Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)01222-8.
~14 spots leftby Apr 2025
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