Home » Clinical Trials » Leukemia » NCT03624036
NCT03624036

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor. After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).

Want to learn more about this trial?

Request More Info

Interventions

brexucabtagene autoleucelBIOLOGICAL
CAR-transduced autologous T cells administered intravenously
FludarabineDRUG
Administered intravenously
CyclophosphamideDRUG
Administered intravenously

Study Locations

FacilityCityStateCountry
Mayo Clinic - ArizonaPhoenixArizonaUnited States
University of California Los Angeles (UCLA)Los AngelesCaliforniaUnited States
Stanford UniversityStanfordCaliforniaUnited States
Sarah Cannon - DenverDenverColoradoUnited States
Moffitt Cancer CenterTampaFloridaUnited States
Emory UniversityAtlantaGeorgiaUnited States
University of Kansas Cancer CenterWestwoodKansasUnited States
Dana Farber Cancer InstituteBostonMassachusettsUnited States
Mayo ClinicRochesterMinnesotaUnited States
Washington University School of MedicineSt LouisMissouriUnited States
Hackensack University Medical CenterHackensackNew JerseyUnited States
Memorial Sloan-KetteringNew YorkNew YorkUnited States
University of RochesterRochesterNew YorkUnited States
Cleveland Clinic - Taussig Cancer InstituteClevelandOhioUnited States
Ohio State UniversityColumbusOhioUnited States
Fox Chase Cancer CenterPhiladelphiaPennsylvaniaUnited States
Sarah Cannon Research CenterNashvilleTennesseeUnited States
Vanderbilt UniversityNashvilleTennesseeUnited States
Baylor Cancer HospitalDallasTexasUnited States
MD Anderson Cancer CenterHoustonTexasUnited States
Swedish Cancer InstituteSeattleWashingtonUnited States
IRCCS Ospedale San RaffaeleMilanItaly

Official Trial Information

View on ClinicalTrials.gov

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