A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

March 7, 2016

Primary Completion Date

July 23, 2022

Study Completion Date

November 3, 2023

Conditions
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Interventions
BIOLOGICAL

brexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.

DRUG

Cyclophosphamide

Administered intravenously.

DRUG

Fludarabine

Administered intravenously.

Trial Locations (33)

10029

Mount Sinai Tisch Cancer Institute, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

13009

Institut Paoli Calmettes, Marseille

14642

University of Rochester, New York

21201

University of MD Greenbaum Comprehensive Cancer Center, Baltimore

30322

Emory University, Atlanta

33604

Hopital Haut-Leveque, Pessac

33612

H Lee Moffitt Cancer Center, Tampa

35033

Hopital Pontchaillou - CHU de Rennes - Service d'Hematologie, Rennes

37203

Sarah Cannon, Nashville

37232

Vanderbilt-Ingram Cancer Center, Nashville

55905

Mayo Clinic, Rochester

60153

Loyola University, Chicago

60590

Universitatsklinikum Frankfurt, Frankfurt

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

75010

Hopital Saint Louis, Paris

75246

Baylor Charles A. Sammons Cancer Center, Dallas

77030

University of Texas MD Anderson Cancer Center, Houston

81377

Klinikum der Universitat Munchen, München

90095

University of California Los Angeles (UCLA), Los Angeles

92093

UC San Diego-Moores Cancer Center, La Jolla

92868

University of California Irvine Medical Center, Orange

94143

University of California San Francisco, San Francisco

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97080

Universitaetsklinikum Wuerzburg, Würzburg

98104

Swedish Cancer Institute, Seattle

98109

Seattle Cancer Center, Seattle

02215

Dana Farber Cancer Institute, Boston

M5G 2M9

University Health Network - Princess Margaret, Toronto

1105 AZ

Amsterdam UMC, Amsterdam

3015 CE

Erasmus MC, Rotterdam

3508 GA

Universitair Medisch Centrum Utrecht, Utrecht

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY

NCT02614066 - A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) | Biotech Hunter | Biotech Hunter