eligibility_summary
Adults 18–75 with active MM per IMWG and measurable disease, ≥3 prior lines incl PI, IMiD, anti‑CD38, PD during/≤12 mo of last therapy, ECOG 0–1, life ≥3 mo, adequate organ function (incl LVEF ≥45%), venous access, contraception, consent. Exclude prior CAR‑T, recent steroids/therapy/vaccines/transplant, major cardiac/respiratory/bleeding/autoimmune/CNS disease, active HBV/HCV/HIV/syphilis, other cancer, pregnancy, unresolved toxicities, investigator concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: GC012F, an autologous, dual-target chimeric antigen receptor T-cell (CAR-T) therapy directed at BCMA and CD19. Patients undergo leukapheresis to manufacture CAR-T cells, receive lymphodepletion with fludarabine (antimetabolite inhibiting DNA synthesis) and cyclophosphamide (alkylator), then GC012F infusion. Mechanism of action: CAR-T cells recognize BCMA (TNFRSF17) on malignant plasma cells and CD19 on B-lineage cells, triggering T-cell activation, cytokine release, and cytotoxic killing (perforin/granzyme). Dual targeting is intended to reduce antigen escape and deepen responses. Cells/pathways targeted: BCMA-driven BAFF/APRIL survival signaling in plasma cells, CD19 within the B-cell receptor co-receptor pathway on B cells/plasma cell precursors, overall depletion of myeloma cells and B-cell compartments. Design: single-arm, open-label Phase I/II in relapsed/refractory multiple myeloma.