eligibility_summary
Eligibility: Adults 18–80 with relapsed/refractory BCMA+ multiple myeloma, ECOG ≤2/KPS >60, life expectancy >3 mo, adequate organ function (liver/kidney, heart EF ≥40%, SpO2 ≥92%), ALC ≥0.5, PLT >30, Hb >80, venous access, agree to contraception, consent. Exclude: pregnancy, positive HBV/HCV/HIV/syphilis/CMV, other active cancers, prior anti-BCMA, recent auto-HSCT, uncontrolled infection, severe allergy/autoimmune/GI bleed/psychiatric issues, recent investigational drugs, or per PI.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous BCMA-directed CAR‑T cell therapy (biological, gene‑modified cell therapy). Mechanism: Patient PBMCs are collected, T cells are engineered ex vivo to express a chimeric antigen receptor that binds BCMA on myeloma cells. After lymphodepleting chemotherapy, CAR‑T cells are infused, CAR engagement activates T cells via CAR signaling domains (CD3ζ with costimulation), driving expansion, cytokine release, and perforin/granzyme‑mediated cytotoxicity. Targets: BCMA (TNFRSF17) expressed on malignant plasma cells in relapsed/refractory multiple myeloma, impacting the BAFF/APRIL–BCMA survival pathway, effector cells are autologous T lymphocytes. Phase 2, single‑arm, treatment‑intent study.