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A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy B – Relapsed/Refractory Richter Transformation (RT)
EU CTIS ID: 2022-501260-18-00
What this study is testing
The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy B (RT) is to evaluate the efficacy of brexucabtagene autoleucel on diffuse large B cell lymphoma (DLBCL)-RT in subjects with RT, by determining the objective response rate (ORR) by central assessment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •Male or female 18 years of age or older at the time of signing the informed consent
- • At least 1 measurable lesion based on the Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
- •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
- •ECOG performance status score of 0 or 1.
- •Adequate hematologic and end-organ function.
- •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
You likely can't join if
- •Prior CAR therapy or treatment with any anti-CD19 therapy
- •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
- •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
- •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- • Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma and prolymphocytic leukemia)
- •Prior allogeneic stem cell transplant < 3 months prior to screening and/or <4 months prior to planned infusion of brexucabtagene autoleucel.
See the full eligibility criteria
- •Male or female 18 years of age or older at the time of signing the informed consent
- • At least 1 measurable lesion based on the Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
- •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
- •ECOG performance status score of 0 or 1.
- •Adequate hematologic and end-organ function.
- •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
- • Confirmed diagnosis of CLL based on IWCLL 2018 criteria Hallek et al 2018 (Substudy protocol section 12.3.2), with histologically confirmed RT to a DLBCL subtype
- • Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:
- a) Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy
- b) Relapsed disease, defined as complete remission to first-line therapy followed by biopsy proven disease relapse
- •Prior CAR therapy or treatment with any anti-CD19 therapy
- •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
- •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
- •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- • Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma and prolymphocytic leukemia)
- •Prior allogeneic stem cell transplant < 3 months prior to screening and/or <4 months prior to planned infusion of brexucabtagene autoleucel.
- •Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.