NCT05537766

A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)

Study 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).

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Interventions

Brexucabtagene AutoleucelBIOLOGICAL
Administered intravenously
CyclophosphamideDRUG
Administered intravenously
FludarabineDRUG
Administered intravenously

Study Locations

FacilityCityStateCountry
City of Hope (City of Hope National Medical Center)DuarteCaliforniaUnited States
Stanford Cancer InstituteStanfordCaliforniaUnited States
Colorado Blood Cancer InstituteDenverColoradoUnited States
Georgetown University Medical CentreWashington D.C.District of ColumbiaUnited States
University of IowaIowa CityIowaUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Hackensack University Medical CenterHackensackNew JerseyUnited States
The Ohio State University Wexner Medical Center - James Cancer HospitalSColumbusOhioUnited States
UPMC Hillman Cancer CenterPittsburghPennsylvaniaUnited States
Tennessee Oncology, PLLCNashvilleTennesseeUnited States
Vanderbilt UniversityNashvilleTennesseeUnited States
MD Anderson Cancer CenterHoustonTexasUnited States
Medical University of Vienna, Department of Internal Medicine I, Div. of HematologyViennaAustria
Hopital de la Pitie SalpetriereParisFrance
Centre hospitalier de Toulouse - Hematology departmentToulouseFrance
Universitatsklinikum KolnCologneGermany
Universitatsklinikum HeidelbergHeidelbergGermany
Universitatsklinikum UlmUlmGermany
IRCCS Azienda Ospedaliero - Universitaria di BolognaBolognaItaly
ASST Grande Ospedale Metropolitano NiguardaMilanItaly
Azienda Ospedale di Perugia - Ospedale S. Maria della MisericordiaPerugiaItaly
Radboud University Nijmegen Medical CentreNijmegenNetherlands
Hospital Clinic de BarcelonaBarcelonaSpain
Hospital Universitario de SalamancaSalamancaSpain
Hospital Universitario Virgen del RocioSevilleSpain
Istituto Oncologico Della Svizzera Italiana (IOSI)BellinzonaSwitzerland

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026