Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
Who is this study for? Patients with relapsed/refractory multiple myeloma
What treatments are being studied? P-BCMA-ALLO1 CAR-T cells
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must have signed written, informed consent.
• Males or females, ≥18 years of age.
• Must have a confirmed diagnosis of active MM.
• Must have measurable MM.
• Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
• Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
• Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential).
• Must be at least 90 days since autologous stem cell transplant, if performed.
• Must have adequate vital organ function within pre-determined parameters.
⁃ Must have recovered from toxicities due to prior therapies.
⁃ Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Locations
United States
Arizona
City of Hope
RECRUITING
Goodyear
California
University of California San Diego
RECRUITING
San Diego
University of California San Francisco
TERMINATED
San Francisco
Georgia
Blood Marrow and Transplant Group of Georgia
RECRUITING
Atlanta
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
City of Hope
RECRUITING
Chicago
Advocate Aurora Health
TERMINATED
Park Ridge
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
Wayne State - Karmanos Cancer Institute
RECRUITING
Detroit
North Carolina
University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
University of Oklahoma, Health Sciences Center
ACTIVE_NOT_RECRUITING
Oklahoma City
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Sarah Cannon Research Institute - St. David's South Austin Medical Center
RECRUITING
Austin
Houston Methodist Research Institute
RECRUITING
Houston
Sarah Cannon Research Institute - Methodist Healthcare
RECRUITING
San Antonio
Contact Information
Primary
Angie Schinkel
clinicaltrials@poseida.com
858-779-3103
Time Frame
Start Date: 2022-05-05
Estimated Completion Date: 2039-12
Participants
Target number of participants: 231
Treatments
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm S)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm F)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm N)
Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm P1)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm P2)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm R)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm RS)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm C)
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm160)
Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm480)
Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm P1.5)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm RP1)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm RP2)
Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm CP1)
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5.~Rimiducid may be administered as indicated.
Experimental: P-BCMA-ALLO1 CAR-T cells (Arm CP2)
Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2.~Rimiducid may be administered as indicated.
Related Therapeutic Areas
Sponsors
Leads: Poseida Therapeutics, Inc.
Collaborators: Roche-Genentech