eligibility_summary
Adults ≥18 with symptomatic, measurable MM, prior PR or better, post-ASCT or ≥2 prior lines (incl IMiD and/or daratumumab), relapsed/refractory to last line, ECOG 0–2, adequate organs, eligible for daratumumab/lenalidomide, TE prophylaxis, agree to biopsies and contraception. Exclude recent investigational/active MM therapy, recent dara/steroids/radiation/surgery, recent auto/any allo HCT, drug hypersensitivity, major comorbidity/infection, QTcF>480, severe liver disease, pregnancy, uncontrolled HIV/HBV/HCV, live vaccine <30d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label study (terminated for low accrual) of ANV419 (engineered IL-2/anti–IL-2 complex, IL‑2Rβγ‑selective cytokine agonist, IV Q2W) as monotherapy and combined with lenalidomide + low‑dose dexamethasone or daratumumab in relapsed/refractory multiple myeloma. Mechanisms: ANV419 biases IL‑2 signaling to IL‑2Rβγ to expand/activate cytotoxic CD8+ T cells and NK cells while minimizing CD25+ Treg activation. Lenalidomide (IMiD, cereblon modulator) degrades Ikaros/Aiolos, boosting T/NK immunity and exerting anti‑myeloma effects, dexamethasone (glucocorticoid) promotes myeloma cell apoptosis. Daratumumab (anti‑CD38 mAb) targets plasma cells, inducing CDC, ADCC, and ADCP. Targets/pathways: IL‑2Rβγ–JAK/STAT on CD8/NK, CRBN‑IKZF1/3 axis, and CD38 on malignant plasma cells.