Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (NCT05537766) | Clinical Trial Compass
TerminatedPhase 2
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
Stopped: Sponsor decision to terminate study.
United States, Austria, France19 participantsStarted 2022-11-01
Plain-language summary
Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
All Substudies:
* Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate hematologic and end-organ function.
* Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
Substudy B:
* 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.
* Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:
* Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy.
* Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
* At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Substudy C:
* Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia.
* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:
* Refractory disease, defined as progressive disease or stable d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Up to 2 years
2
Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification
Timeframe: Up to 2 years
3
Substudy C: ORR Determined by Central Assessment Per the Lugano Classification
Timeframe: Up to 2 years
4
Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues