Spots Global Cancer Trial Database for P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
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Trial Identification
Brief Title: P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Official Title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies
Study ID: NCT06014762
Study Description
Brief Summary: Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies
Detailed Description: Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts to define a maximum tolerated dose (MTD). Part 2 includes administration at a selected dose and LD regimen. After enrollment, subjects may receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single dose. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, La Jolla, California, United States
Loma Linda University Cancer Center, Loma Linda, California, United States
Wayne State - Karmanos Cancer Institute, Detroit, Michigan, United States
Weill Cornell Medicine, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, United States
Prisma Health - Upstate Cancer Institute, Greenville, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor Scott & White Research Institute, Dallas, Texas, United States
Contact Details
Name: Rajesh Belani, MD
Affiliation: Vice President, Clinical Development
Role: STUDY_DIRECTOR
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