← Back to Search

CAR T-cell Therapy

Gene Therapy for Rare B-Cell Cancers (ZUMA-25 Trial)

Phase 2
Recruiting
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
Adequate hematologic and end-organ function
Confirmed diagnosis of chronic lymphocytic leukemia (CLL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria with histologically confirmed Richter transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years for substudies b and c; up to 5 years for substudies a and d
Awards & highlights

ZUMA-25 Trial Summary

This trial studies a new gene therapy to treat 4 rare B-cell malignancies, such as Waldenstrom macroglobulinemia, Richter transformation, Burkitt lymphoma, and hairy cell leukemia.

Who is the study for?
Adults with certain rare B-cell malignancies like Richter Transformation, Burkitt Lymphoma, and Waldenstrom Macroglobulinemia can join if they've recovered from previous treatments to a mild level, have good physical function, and proper organ function. They must use contraception if applicable. Those who've had recent CAR therapy or stem cell transplants, CNS involvement, autoimmune diseases or HIV not well-controlled are excluded.Check my eligibility
What is being tested?
The trial is testing brexucabtagene autoleucel's effectiveness on various subtypes of B-cell malignancies. Participants will also receive fludarabine and cyclophosphamide as part of the treatment regimen. The study includes different substudies for each condition but some are no longer recruiting.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue, blood count abnormalities that could lead to infections or bleeding problems, and possible damage to organs due to the body's response against cancer cells.

ZUMA-25 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood and organs are functioning well.
Select...
I have chronic lymphocytic leukemia that has transformed into a more aggressive type.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
Any side effects from my previous treatments are mild or gone.
Select...
My condition worsened or didn't improve after one treatment, and I have at least one measurable tumor.

ZUMA-25 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years for substudies b and c; up to 5 years for substudies a and d
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for substudies b and c; up to 5 years for substudies a and d for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM)
Substudy B: Objective Response Rate (ORR) Determined by Central Assessment per the Lugano Classification
Substudy C: ORR Determined by Central Assessment per the Lugano Classification
+1 more
Secondary outcome measures
All Substudies (Substudies A, B, C and D): Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score
All Substudies (Substudies A, B, C and D): Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score
All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment
+20 more

ZUMA-25 Trial Design

4Treatment groups
Experimental Treatment
Group I: Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene AutoleucelExperimental Treatment3 Interventions
Participants will receive fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2 × 10^6 anti-CD19 CAR T cells/kg. This arm is no longer recruiting.
Group II: Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene AutoleucelExperimental Treatment3 Interventions
Participants will receive fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2x10^6 anti-CD19 CAR T cells/kg.
Group III: Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene AutoleucelExperimental Treatment3 Interventions
Participants will receive fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2×10^6 anti-CD19 CAR T cells/kg.
Group IV: Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene AutoleucelExperimental Treatment3 Interventions
Participants will receive fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2 × 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg. This arm is no longer recruiting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,561 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,919 Total Patients Enrolled

Media Library

Brexucabtagene Autoleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05537766 — Phase 2
Burkitt Lymphoma Research Study Groups: Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel, Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel, Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel, Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
Burkitt Lymphoma Clinical Trial 2023: Brexucabtagene Autoleucel Highlights & Side Effects. Trial Name: NCT05537766 — Phase 2
Brexucabtagene Autoleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537766 — Phase 2

Frequently Asked Questions

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

Has the Food and Drug Administration authorized Brexucabtagene Autoleucel for Relapsed/Refractory hairy cell leukemia in Substudy D?

"Our team rated the safety of Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel a 2 due to available Phase 2 data that affirms its security, yet there is no evidence confirming its efficacy."

Answered by AI

Is the research team enrolling any additional participants in this experiment?

"Affirmative, according to clinicaltrials.gov records this medical investigation is currently recruiting patients. It was first published on November 1st 2022 and recently updated on the fifteenth of November; 170 individuals from two trial sites are sought after."

Answered by AI

How many participants are actively involved in this research endeavor?

"Affirmative, the information listed on clinicaltrials.gov confirms that this research study is actively recruiting participants. The trial was initially posted in November 1st 2022 and has been revised as of 15th of the same month. Up to 170 individuals will be accepted into the experiment through two different medical facilities."

Answered by AI
~60 spots leftby Dec 2027