eligibility_summary
Include: 18–75, consented, relapsed/refractory plasma cell malignancy after ≥3 lines incl. PI+IMiD, progression/measurable disease (M‑protein, FLC or ≥10% marrow), ECOG 0–2, adequate organ/cardiopulmonary function, contraception (neg pregnancy test if applicable). Exclude: CNS disease, other uncontrolled cancer, major CV/neuro disease, serious comorbidity, allo‑HSCT <6 mo or GVHD therapy, autoimmune/immunodeficiency or immunosuppressants, uncontrolled infection or live vaccine <4 wks, active HBV/HCV/HIV/CMV or syphilis, substance abuse/psychiatric illness, unmet washouts, investigator discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SENL103, an autologous BCMA-directed CAR-T cell therapy (gene-modified T cells). Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds BCMA on malignant plasma cells, leading to T-cell activation, cytokine release, and targeted cytotoxic killing of myeloma cells. Targets: BCMA (B-cell maturation antigen) on plasma cells, downstream T-cell effector signaling (via CAR activation) and cytokine pathways. Study design: single-arm, 3+3 dose escalation (1–3×10^6 CAR-T/kg) in relapsed/refractory multiple myeloma. Primary aim: safety (cytokine release syndrome, neurotoxicity). Secondary: efficacy (sCR/CR/VGPR/PR/MR/SD, PFS), pharmacokinetics (CAR-T expansion/persistence), and pharmacodynamics (peripheral plasma cell levels, free BCMA, cytokine kinetics).