eligibility_summary
Adults ≥18 with R/R hematologic cancers (incl. MM, CLL, WM, amyloidosis, HL/NHL). Phase Ib: MM after ≥3 regimens (PI, CD38 Ab, IMiD), DLBCL R/R after 1L and salvage/auto-HCT. ECOG ≤2, life ≥12 wks, adequate marrow, hepatic, renal, cardiac function. Contraception required. Exclude: active CNS disease, hemolysis/DAT+, major cardiac/thrombotic events, active infections, recent therapy/surgery, prior anti-CD47/SIRPα, pregnancy, autoimmune on systemic tx, high-dose steroids, recent allo-SCT/GVHD, lung disease, live vaccine, infusion intolerance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05293912: First‑in‑human Phase Ia/Ib, single‑arm, open‑label study of SG2501 in relapsed/refractory hematologic malignancies, with expansion in MM and DLBCL. Intervention: SG2501, a recombinant bispecific monoclonal antibody against CD38 and CD47, IV weekly (0.01–6 mg/kg). Mechanism of action: • CD47 blockade inhibits the CD47–SIRPα “don’t‑eat‑me” checkpoint, promoting macrophage‑mediated phagocytosis. • CD38 engagement targets malignant plasma/B cells and can induce Fc‑mediated ADCC (via NK/monocytes) and complement‑dependent cytotoxicity, CD38 inhibition may also reduce adenosine‑mediated immunosuppression and deliver pro‑apoptotic signaling. Cells/pathways targeted: CD38+ tumor cells (MM, DLBCL, CLL, WM, NHL), macrophages via SIRPα, NK cells via Fcγ receptors, and the complement cascade. Primary focus: safety/PK/PD, status: terminated (development plan adjustment).