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NCT04404660

An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia

Study Summary

This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (ALL).

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Interventions

AUTO1BIOLOGICAL
Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).

Study Locations

FacilityCityStateCountry
City of Hope National Medical CenterDuarteCaliforniaUnited States
University of California San Diego Health (UCSD)La JollaCaliforniaUnited States
University of California Davis (UC Davis)SacramentoCaliforniaUnited States
University of California San Francisco (UCSF)San FranciscoCaliforniaUnited States
Colorado Blood Cancer Institute (CBCI)DenverColoradoUnited States
University of MiamiMiamiFloridaUnited States
H Lee Moffitt Cancer CenterTampaFloridaUnited States
Winship Cancer Institute of Emory UniversityAtlantaGeorgiaUnited States
University of ChicagoChicagoIllinoisUnited States
University of KansasKansas CityKansasUnited States
University of Maryland Medical CenterBaltimoreMarylandUnited States
Dana-Farber Cancer InstituteBostonMassachusettsUnited States
Mayo ClinicRochesterMinnesotaUnited States
Washington University School of MedicineSt LouisMissouriUnited States
University of NebraskaOmahaNebraskaUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
University of RochesterRochesterNew YorkUnited States
Cleveland ClinicClevelandOhioUnited States
TriStar Centennial Medical Center (SCRI)NashvilleTennesseeUnited States
Baylor Scott & White Research InstituteDallasTexasUnited States
MD Anderson Cancer CenterHoustonTexasUnited States
TTI-Methodist (Texas Transplant Institute) (SCRI)San AntonioTexasUnited States
The Medical College of WisconsinMilwaukeeWisconsinUnited States
Fundacio' Hospital Universitari Vall d'HebronBarcelonaSpain
Hospital Universitario Virgen del RocíoSevilleSpain
Hospital Universitario La FéValenciaSpain
Cambridge University Hospitals NHS Foundation TrustCambridgeCambridgeshireUnited Kingdom
University College London Hospitals NHS Foundation TrustLondonGreater LondonUnited Kingdom
King's College HospitalLondonGreater LondonUnited Kingdom
Manchester Royal Infirmary HospitalManchesterGreater ManchesterUnited Kingdom
Queen Elizabeth University HospitalGlasgowScotlandUnited Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneTyne and WearUnited Kingdom
University Hospitals Birmingham NHS Foundation TrustBirminghamWest MidlandsUnited Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)BristolUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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