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Gene Therapy for Rare B-Cell Cancers (ZUMA-25 Trial)
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.
ZUMA-25 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowZUMA-25 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ZUMA-25 Trial Design
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Who is running the clinical trial?
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- You have certain types of lymphoma, had a stem cell transplant in the past 3 months, have active graft-versus-host disease, or your cancer has spread to your central nervous system.I have a type of lymphoma that is not DLBCL, had a stem cell transplant less than 3 months ago, and I don't have active graft-versus-host disease.My blood and organs are functioning well.I have chronic lymphocytic leukemia that has transformed into a more aggressive type.I am fully active or restricted in physically strenuous activity but can do light work.Any side effects from my previous treatments are mild or gone.I have not had CAR therapy or anti-CD19 treatment.My cancer has spread to my brain or spinal fluid.I have an autoimmune disease like Crohn's, rheumatoid arthritis, or lupus.My condition worsened or didn't improve after one treatment, and I have at least one measurable tumor.I am HIV-positive, on treatment, with undetectable viral load and CD4 count over 200.
- Group 1: Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
- Group 2: Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
- Group 3: Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
- Group 4: Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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