eligibility_summary
Adults (≥18) with high‑risk NDMM (R2‑ISS III/IV) post‑ASCT (screen ≤100 d, if consolidation, ≤60 d and ≤6 mo post‑ASCT) with detectable MRD (≥10^-5). Adequate liver, renal (CrCl>60), blood counts, able to take anticoagulant prophylaxis, effective contraception. Exclude: PCL, amyloidosis, CNS MM, prior maintenance, BCMA/CAR‑T, ≥G2 neuropathy, BCMA intolerance, HIV/HBV/HCV, life expectancy <3 mo, pregnancy/breastfeeding, recent major surgery, live vaccine, contraindications/compliance issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05846737 tests autologous anti-BCMA CAR-T cells (biologic, cellular gene therapy) in high-risk newly diagnosed multiple myeloma patients with MRD positivity after first-line ASCT. Intervention: intravenous infusion of 2–4 ×10^6 BCMA CAR+ T cells/kg. Mechanism: patient T cells are gene-engineered to express a chimeric antigen receptor that binds BCMA (TNFRSF17) on myeloma/plasma cells, engagement triggers CAR signaling to activate T-cell cytotoxicity and cytokine release, eliminating residual disease. Targets: BCMA on malignant plasma cells and the BCMA–BAFF/APRIL survival pathway, leverages T-cell effector pathways (CD3ζ-driven activation).