Spots Global Cancer Trial Database for P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
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Trial Identification
Brief Title: P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Official Title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
Study ID: NCT04960579
Conditions
Study Description
Brief Summary: Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).
Detailed Description: Phase 1/1b study: Phase 1 Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts. Phase 1 Part 2 includes administration at fixed doses. After enrollment, subjects may receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single or multiple doses. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated. Phase 1b of the study will undergo further expansion of cohorts/arms from Phase 1 Parts 1 or 2 to guide selection of Recommended Phase 2 Dose (RP2D).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Advocate Aurora Health, Park Ridge, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Wayne State - Karmanos Cancer Institute, Detroit, Michigan, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Sarah Cannon Research Institute - St. David's South Austin Medical Center, Austin, Texas, United States
Houston Methodist Research Institute, Houston, Texas, United States
Sarah Cannon Research Institute - Methodist Healthcare, San Antonio, Texas, United States
Contact Details
Name: Rajesh Belani, M.D.
Affiliation: Vice President, Clinical Development
Role: STUDY_DIRECTOR
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