Spots Global Cancer Trial Database for CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma
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Trial Identification
Brief Title: CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma
Official Title: A Single Arm, Open-label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 With Anti PD1 Antibody in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
Study ID: NCT03287817
Interventions
Study Description
Brief Summary: The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 followed by limited duration of anti-PD1 antibody in patients with DLBCL
Detailed Description: The study will consist of 2 phases, a Phase I or dose escalation and expansion phase, and a Phase II. Patients with relapsed or refractory DLBCL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3 which is a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO 3 intravenously as a single dose and in addition a limited duration of treatment with an anti-PD1 antibody (either as part of the pre-conditioning regimen or consolidation). Patients will then enter a 36-month follow-up period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Hospital, Duarte, California, United States
Colorado Blood Cancer Institute at Presbyterian/St. Luke's Medical Center/Sarah Cannon Research Institute, Denver, Colorado, United States
Sylvester Comprehensive Cancer Center / University of Miami, Miami, Florida, United States
Siteman Cancer Center / Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
TriStar Centennial Medical Center /Sarah Cannon Research Institute, Nashville, Tennessee, United States
St David's South Austin Medical Center /Sarah Cannon Research Institute, Austin, Texas, United States
The Beatson West of Scotland Cancer Centre / Queen Elizabeth University Hospital, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Manchester University NHS Foundation Trust, Manchester, , United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, , United Kingdom
Contact Details
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