eligibility_summary
Incl: MM per IMWG with measurable disease (SPEP M≥0.5 g/dL, UPEP≥200 mg/24h, or FLC≥10 mg/dL with abnormal ratio), ECOG 0–2. P1: ≥3 prior lines incl PI, IMiD, anti‑CD38 or triple‑refractory. P2a: 1–3 lines, lenalidomide‑refractory, anti‑CD38 naïve/sensitive, PD after last regimen, prior PR+. Excl: prior modakafusp, POEMS/amyloid/WM/PCL/SP/LPL, AEs>Gr1, prior allo SCT/recent ASCT, HBV/HCV/HIV, cardiac disease/QTcF>480ms, chronic steroids>10 mg/d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests modakafusp alfa (TAK-573) plus daratumumab in relapsed/refractory multiple myeloma. Modakafusp alfa: anti‑CD38 immunocytokine/fusion protein that targets CD38 and delivers attenuated interferon‑α to CD38+ cells, activating type I IFN signaling (IFNAR1/2 → JAK–STAT) for direct antiproliferative/apoptotic effects and immune stimulation. Daratumumab: anti‑CD38 IgG1 monoclonal antibody inducing ADCC, ADCP, complement‑dependent cytotoxicity, apoptosis via crosslinking, and immunomodulation (depletion of CD38+ suppressor cells). Cells/pathways targeted: CD38+ malignant plasma cells and CD38+ immune subsets, type I interferon pathway (IFNAR/JAK–STAT), NK cell/cytotoxic effector mechanisms, complement cascade. Study terminated after Phase 1 for strategic reasons.