NCT04960579

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Poseida Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	P-BCMA-ALLO1 CAR-T cells	Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
DRUG	Rimiducid	Safety switch activator
DRUG	Methotrexate	Anti-metabolite

Timeline

• Start date: 2022-05-05
• Primary completion: 2029-03-01
• Completion: 2042-03-01
• First posted: 2021-07-14
• Last updated: 2026-04-09

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study