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A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Sponsor: Autolus Limited
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2020-06-03
Completion Date
2029-06-30
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
AUTO1
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).
Locations (34)
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Health (UCSD)
La Jolla, California, United States
University of California Davis (UC Davis)
Sacramento, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
TTI-Methodist (Texas Transplant Institute) (SCRI)
San Antonio, Texas, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Fundacio' Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario La Fé
Valencia, Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
Manchester Royal Infirmary Hospital
Manchester, Greater Manchester, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Bristol, United Kingdom