Spots Global Cancer Trial Database for P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
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Trial Identification
Brief Title: P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Official Title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)
Study ID: NCT03288493
Conditions
Study Description
Brief Summary: Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.
Detailed Description: Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of California Davis, Davis, California, United States
University of California San Diego, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Chicago, Chicago, Illinois, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Johns Hopkins University, Baltimore, Maryland, United States
Wayne State - Karmanos Cancer Institute, Detroit, Michigan, United States
John Theurer Cancer Center, Hackensack, New Jersey, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
Name: Rajesh Belani, M.D.
Affiliation: Sponsor Executive Medical Director
Role: STUDY_DIRECTOR
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