eligibility_summary
Adults 18–75 with relapsed/refractory multiple myeloma after ≥3 prior lines (incl PI and IMiD), BCMA+ tumor, IMWG-defined progression, ECOG 0–2, ≥12-week survival, and adequate organ function, contraception and consent required. Exclude active HBV/HCV/HIV/syphilis, recent chemo/biologics/steroids/vaccines/surgeries, prior allo-HSCT/solid organ transplant, plasma cell leukemia/CNS disease, other recent cancers, severe infections/comorbidities, pregnancy, other trials, severe allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CG-105-12, an autologous BCMA-directed chimeric antigen receptor (CAR) T-cell therapy (biologic, cell/gene therapy). Mechanism of action: patient T cells are collected, genetically engineered to express a CAR that binds B-cell maturation antigen (BCMA, TNFRSF17) on myeloma cells, expanded, and reinfused. CAR engagement triggers T-cell activation (via CD3ζ signaling and costimulation), proliferation, cytokine release, and cytotoxic killing (perforin/granzymes), with potential persistence for ongoing tumor surveillance. Targets: BCMA-expressing malignant plasma cells in relapsed/refractory multiple myeloma. Pathways/cells affected: BCMA signaling axis on plasma cells, activated cytotoxic T-cell pathways and immune synapse–mediated lysis. Study design: single-arm, dose-escalation, single-dose to assess safety, tolerability, dose, antitumor activity, and cellular kinetics.