eligibility_summary
Adults ≥18 with high-risk smoldering multiple myeloma (IMWG), measurable disease, ECOG 0–1, adequate counts/renal/hepatic function, no lytic bone lesions, and agreement to contraception/protocol. Exclude prior systemic MM therapy (except 1 cycle with washout), concurrent investigational agents or recent live vaccines, severe cardiac/pulmonary disease, active HBV/HCV or uncontrolled HIV, uncontrolled illness, other active malignancy, serious drug allergy, pregnancy/breastfeeding, or inability to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, sequential-cohort trial in high‑risk smoldering multiple myeloma testing two combinations: 1) Teclistamab + daratumumab SC, 2) Talquetamab + daratumumab SC. Teclistamab: bispecific T‑cell–engaging antibody (BCMA×CD3) that redirects cytotoxic T cells to kill BCMA+ malignant plasma cells. Talquetamab: bispecific T‑cell–engaging antibody (GPRC5D×CD3) that redirects T cells to GPRC5D+ myeloma cells. Daratumumab SC: anti‑CD38 IgG1 monoclonal antibody that depletes CD38+ plasma cells and immunosuppressive cells via ADCC/CDC/ADCP and augments T‑cell activity. Targets/pathways: BCMA and GPRC5D on myeloma/plasma cells, CD3 on T cells (T‑cell activation/synapse formation), CD38 on plasma cells/immune subsets (Fc‑mediated cytotoxicity). Aim: delay progression by dual targeting of myeloma antigens plus immune modulation.