eligibility_summary
Adults ≥18, ECOG 0–2, >3‑mo survival, untreated AML unfit for induction or untreated higher‑risk MDS (IPSS‑R>3.5, blasts ≥5%), adequate organ function, consent, biopsies, contraception. Exclude CNS leukemia, recent/active other cancers, uncontrolled effusions, prior CD47/SIRPα therapy, recent major anti‑tumor therapy/transplant, significant hepatic/renal/GI/CNS/cardiac/thrombotic/pulmonary/immunodef/infectious disorders, hemolysis, specific MDS/AML types, recent vaccines/trials, allergy to mAbs/Ig, azacitidine or mannitol.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib single-arm trial in AML/MDS testing TQB2928 plus azacitidine. TQB2928 is a fully humanized IgG4 monoclonal antibody against CD47. Mechanism: blocks the CD47/SIRPα innate immune checkpoint, removing the “don’t-eat-me” signal on leukemic/MDS cells to enhance macrophage-mediated phagocytosis and potentially antigen presentation. Azacitidine is a hypomethylating nucleoside analog (DNMT inhibitor) that reduces DNA methylation, reactivates silenced genes, and promotes differentiation/apoptosis of malignant myeloid cells. Targets/pathways: CD47 on leukemia/MDS blasts, SIRPα signaling on macrophages, innate immune phagocytosis, epigenetic DNMT pathway. Regimen: weekly IV TQB2928 + azacitidine 75 mg/m2 days 1–7 every 28 days. Objectives: safety, PK/PD, and MTD/OBD/RP2D with preliminary efficacy.