Spots Global Cancer Trial Database for A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
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Trial Identification
Brief Title: A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (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
Study ID: NCT04404660
Interventions
Study Description
Brief Summary: This is a Phase Ib/II 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 B cell acute lymphoblastic leukemia (ALL).
Detailed Description: This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR). Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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, Sevilla, , 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
Contact Details
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