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NCT02614066

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

Study Summary

The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

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Interventions

brexucabtagene autoleucelBIOLOGICAL
A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.
CyclophosphamideDRUG
Administered intravenously.
FludarabineDRUG
Administered intravenously.

Study Locations

FacilityCityStateCountry
UC San Diego-Moores Cancer CenterLa JollaCaliforniaUnited States
University of California Los Angeles (UCLA)Los AngelesCaliforniaUnited States
University of California Irvine Medical CenterOrangeCaliforniaUnited States
University of California Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States
University of California San FranciscoSan FranciscoCaliforniaUnited States
H Lee Moffitt Cancer CenterTampaFloridaUnited States
Emory UniversityAtlantaGeorgiaUnited States
Loyola UniversityChicagoIllinoisUnited States
University of ChicagoChicagoIllinoisUnited States
University of MD Greenbaum Comprehensive Cancer CenterBaltimoreMarylandUnited States
Dana Farber Cancer InstituteBostonMassachusettsUnited States
Mayo ClinicRochesterMinnesotaUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Mount Sinai Tisch Cancer InstituteNew YorkNew YorkUnited States
Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States
University of RochesterNew YorkNew YorkUnited States
Sarah CannonNashvilleTennesseeUnited States
Vanderbilt-Ingram Cancer CenterNashvilleTennesseeUnited States
Baylor Charles A. Sammons Cancer CenterDallasTexasUnited States
University of Texas MD Anderson Cancer CenterHoustonTexasUnited States
Swedish Cancer InstituteSeattleWashingtonUnited States
Seattle Cancer CenterSeattleWashingtonUnited States
University Health Network - Princess MargaretTorontoOntarioCanada
Institut Paoli CalmettesMarseilleFrance
Hopital Saint LouisParisFrance
Hopital Haut-LevequePessacFrance
Hopital Pontchaillou - CHU de Rennes - Service d'HematologieRennesFrance
Universitatsklinikum FrankfurtFrankfurtGermany
Klinikum der Universitat MunchenMünchenGermany
Universitaetsklinikum WuerzburgWürzburgGermany
Amsterdam UMCAmsterdamNetherlands
Erasmus MCRotterdamNetherlands
Universitair Medisch Centrum UtrechtUtrechtNetherlands

Official Trial Information

View on ClinicalTrials.gov

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