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).
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 dose(s). 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 or an intermediate dose between cohort levels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Safety switch activator
Anti-metabolite
City of Hope
Goodyear, Arizona, United States
Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)
Rate of dose limiting toxicities (DLT)
Time frame: Baseline through Day 28
Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.
Frequency and severity of adverse events, including cytokine release syndrome.
Time frame: Baseline through 36 months
Phase 1b: The effect of cell dose and study arm
Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria
Time frame: Baseline through 36 months
The safety of P-BCMA-ALLO1
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through 15 years
The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR) - Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR)
Time frame: Baseline through 15 years
Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR) - Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease, Overall response rate (ORR), Duration of response (DOR), Progression free survival (PFS), and Overall survival (OS)
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University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Blood Marrow and Transplant Group of Georgia
Atlanta, Georgia, United States
City of Hope
Chicago, Illinois, 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
...and 13 more locations
Time frame: Baseline through 15 years