Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
brief 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).
detailed description
This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL.
After completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.
All substudies have been early terminated by the sponsor. Below is summary of enrollment in each Substudy:
* Substudy-A This substudy was withdrawn. Therefore no participants were enrolled. * Substudy-B enrollment closed, actual enrollment is 6. * Substudy-C enrollment closed, actual enrollment is 12. * Substudy-D enrollment closed, actual enrollment is 1.
official title
A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)