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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 ~first infusion date of brexucabtagene autoleucel (phase 2) to data cutoff date of 09 september 2020 (maximum duration: 23 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date of brexucabtagene autoleucel (phase 2) to 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
~1080
brexucabtagene autoleucel
2016
Completed Phase 2
~230
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
3,976 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,334 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
~14 spots leftby Jun 2025
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