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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)

  • Protocol Number: 202212028
  • Principal Investigator: Crees, Zachary
  • Cancer Types: Gene & Cellular Immunotherapy, Leukemia, Myeloma, and Hematologic, Lymphoma

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
info@ccadmin.wustl.edu

Brief 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.

Protocol Interventions

Brexucabtagene Autoleucel, Cyclophosphamide, Fludarabine