Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
Status:
Not yet recruiting
Trial end date:
2029-11-01
Target enrollment:
Participant gender:
Summary
Master protocol: The primary objective of this study is to evaluate the efficacy of
brexucabtagene autoleucel in four rare B-cell malignancies. This study will use a basket
study design with separate, indication-specific substudies, to investigate
relapsed/refractory Waldenstrom macroglobulinemia (r/r WM), relapsed/refractory Richter
transformation (r/r RT), relapsed/refractory Burkitt lymphoma (r/r BL), and
relapsed/refractory hairy cell leukemia (r/r HCL).
Substudy A: The primary objective of this substudy is to evaluate the efficacy of
brexucabtagene autoleucel in participants with r/r WM by determining the combined rate of
complete response (CR) and very good partial response (VGPR) by central assessment.
Substudy B: The primary objective of this substudy is to evaluate the efficacy of
brexucabtagene autoleucel on diffuse large B-cell lymphoma-Richter transformation (DLBCL-RT)
in participants with r/r RT, by determining the objective response rate (ORR) by central
assessment.
Substudy C: The primary objective of this substudy is to evaluate the efficacy of
brexucabtagene autoleucel in participants with r/r BL, by determining the ORR by central
assessment.
Substudy D: The primary objective of this substudy is to evaluate the efficacy of
brexucabtagene autoleucel in participants with r/r HCL by determining the ORR by central
assessment.