eligibility_summary
Adults ≥18 with IMWG-defined multiple myeloma: measurable disease (M‑protein/sFLC) or ≥10–20% marrow or high‑risk cytogenetics. ECOG 0–3, life expectancy ≥3 months, adequate counts/renal/hepatic/cardiac function and SpO2, apheresis access, contraception, consent. Exclude: planned auto/allo transplant, PCL/POEMS/amyloidosis/MGUS/SMM, other active cancer, CNS involvement/disease, major cardiac disease, HIV/HBV/HCV/syphilis, autoimmune or lung disease, recent major surgery, pregnancy/lactation, hereditary marrow failure.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: GC012F, an autologous dual-target CAR‑T cell therapy (biologic, gene‑modified T cells) given as a single IV infusion after lymphodepleting chemotherapy. Mechanism: patient T cells are engineered to express CARs recognizing BCMA (TNFRSF17) and CD19, driving antigen‑specific T‑cell activation and cytotoxicity to eliminate malignant plasma cells and B‑cell lineage progenitors, aiming to reduce relapse. Additional protocol drugs: optional bortezomib‑based induction (proteasome inhibitor causing myeloma cell apoptosis) and lenalidomide maintenance from month 6 (IMiD, cereblon‑mediated Ikaros/Aiolos degradation, enhances T/NK activity). Targets/pathways: BCMA on plasma cells (APRIL/BAFF survival axis), CD19 on B cells/myeloma stem‑like cells, proteasome pathway, cereblon E3 ligase, CAR‑T signaling in effector T cells.