NCT02625480

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Study Summary

The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).

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Interventions

Brexucabtagene Autoleucel (KTE-X19)BIOLOGICAL
No description available.
FludarabineDRUG
Administered intravenously
CyclophosphamideDRUG
Administered intravenously

Study Locations

FacilityCityStateCountry
Children's Hospital Los AngelesLos AngelesCaliforniaUnited States
Children's Hospital of Orange CountyOrangeCaliforniaUnited States
UCSF Benioff Children's HospitalSan FranciscoCaliforniaUnited States
University of Miami Hospital & ClinicsMiamiFloridaUnited States
Kapi'olani Medical Center for Women and ChildrenHonoluluHawaiiUnited States
Ann & Robert H. Lurie Children's HospitalChicagoIllinoisUnited States
Johns Hopkins UniversityBaltimoreMarylandUnited States
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesotaUnited States
Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYPNew YorkNew YorkUnited States
University of Rochester Medical CenterRochesterNew YorkUnited States
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Monroe-Carell Jr. Children's Hospital at VanderbiltNashvilleTennesseeUnited States
Texas Children's HospitalHoustonTexasUnited States
The University of Texas M.D. Anderson Cancer CenterHoustonTexasUnited States
University of Virginia Health System, Pediatric Hematology/Oncology ClinicCharlottesvilleVirginiaUnited States
University Hospital GentGhentBelgium
The Hospital for Sick ChildrenTorontoCanada
University Hospital BrnoBrnoCzechia
Unité d'Oncologie et Hématologie PédiatriquesBordeauxFrance
Institut d'Hematologie et Oncologie PediatriqueLyonFrance
Hopital d'Enfants la TimoneMarseilleFrance
Hopital Robert Debre - Sevice d'Hemato-immunologicParisFrance
University Medical Center Hamburg-Eppendorf (UKE)HamburgGermany
Bambino Gesù Children's HospitalRomeItaly
Prinses Maxima CentrumUtrechtNetherlands
Jurasz University Hospital 1; Collegium MedicumBydgoszczPoland
Wroclaw Medical UniversityWroclawPoland
Hospital Sant Joan de DéuBarcelonaSpain
Hospital Universitario La PazMadridSpain
Karolinska University HospitalStockholmSweden

Official Trial Information

View on ClinicalTrials.gov

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