eligibility_summary
Adults ≥18 with relapsed/refractory MM and measurable disease, ≥3 prior lines incl lenalidomide, PI, anti‑CD38/SLAMF7 mAb and BCMA, refractory to last therapy (≥2‑wk washout). ECOG≤2, adequate counts/organ function, LVEF≥30, QTcF≤470, consent/contraception. Exclude: active CNS MM, WM/AL/primary PCL/POEMS, prior allo‑HCT, pulm/cardiac disease, recent trial/surgery, HIV or active HBV/HCV, other malignancy, noncompliance, life exp ≤6mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase Ib single-arm in relapsed/refractory multiple myeloma post-BCMA therapy. Interventions and mechanisms: • Universal donor TGF-β–imprinted expanded NK cells (TiNK) — allogeneic cell therapy, ex vivo TGF-β imprinting makes NK cells resistant to TGF-β–mediated immunosuppression and enhances cytotoxicity/ADCC. • Isatuximab (Sarclisa) — IgG1 monoclonal antibody against CD38, induces ADCC, CDC, and direct apoptosis, opsonizes myeloma for NK killing. • Cyclophosphamide — alkylating agent causing DNA crosslinks, provides tumor cytoreduction and lymphodepletion to support NK-cell activity. • Dexamethasone — corticosteroid, anti-myeloma and anti-inflammatory via glucocorticoid receptor. Targets/cellular pathways: CD38 on malignant plasma cells, NK-cell FcγRIIIa (CD16)-mediated ADCC and granule cytotoxicity, TGF-β immunosuppressive pathway, DNA integrity in dividing cells, glucocorticoid receptor signaling.