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NCT02535364

A Phase 2, Single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Study Summary

This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.

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Interventions

JCAR015 (CD19-targeted CAR T cells)BIOLOGICAL
Part A: Following leukapheresis and concurrent with generation of JCAR015, participants received, at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice of regimens and/or supportive care. Part B: Participants who were eligible for treatment in Part B received two IV doses of JCAR015 CAR T cells separated by 14 to 28 days. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine.

Study Locations

FacilityCityStateCountry
University of Alabama Birmingham Comprehensive Cancer CenterBirminghamAlabamaUnited States
City of HopeDuarteCaliforniaUnited States
University of CaliforniaSan FranciscoCaliforniaUnited States
University of Colorado Denver -- Anschutz Medical CampusAuroraColoradoUnited States
Sylvester Comprehensive Cancer Center/UMHCMiamiFloridaUnited States
The Blood and Marrow Transplant Program at Northside HospitalAtlantaGeorgiaUnited States
Northwestern University Robert H Lurie Comprehensive Cancer CenterChicagoIllinoisUnited States
University of Chicago Medical CenterChicagoIllinoisUnited States
Sidney Kimmel Comprehensive Cancer Center @ Johns HopkinsBaltimoreMarylandUnited States
Massachusetts General HospitalBostonMassachusettsUnited States
Dana-Farber Cancer InstituteBostonMassachusettsUnited States
Washington University School of MedicineSt LouisMissouriUnited States
University of Nebraska Medical CenterOmahaNebraskaUnited States
Roswell Park Cancer InstituteBuffaloNew YorkUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Cleveland ClinicClevelandOhioUnited States
Vanderbilt University Medical CenterNashvilleTennesseeUnited States
MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

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