eligibility_summary
Adults 18–74 with relapsed/refractory multiple myeloma after ≥3 prior lines (must include PI, IMiD, anti‑CD38, prior anti‑BCMA allowed if no ≥grade 3 CRS/ICANS). Must have measurable disease, ECOG 0–1, adequate labs/organ function (ANC ≥1, Plt ≥50, Hb ≥8, AST/ALT ≤2.5×ULN, bilirubin ≤2×ULN, CrCl ≥30), consent, and leukapheresis. Excludes poor CD62L yield, hypersensitivity, recent therapy (<14 d), allo‑HSCT, auto‑HSCT <12 wks, systemic steroids, HIV/active hepatitis, active CNS, SpO2 ≤92%, LVEF ≤45%, pregnancy/breastfeeding, most other recent cancers.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CART-BCMA/CS1, an autologous bispecific CAR-T cell therapy engineered via lentiviral vector to recognize BCMA and CS1 (SLAMF7) on myeloma cells, CAR engagement triggers T-cell activation (CD3ζ/co-stimulatory signaling), cytokine release, and cytotoxic killing. Lymphodepletion: cyclophosphamide (alkylating DNA cross-linker) and fludarabine (purine analog antimetabolite) to deplete host lymphocytes and enhance CAR-T expansion/persistence. Targets/pathways: BCMA on late B-lineage/plasma cells, CS1/SLAMF7 on myeloma/plasma cells, T-cell effector pathways, assessment of cytokine milieu/CRS, T-cell subsets, and plasma-cell aplasia. Status: Phase I, withdrawn before opening.