eligibility_summary
Adults (≥18) with WHO 2022 AML, ECOG 0–3 (0–2 if ≥75), life expectancy ≥12 weeks, adequate organ function, agree to contraception for 120 days post-treatment. Exclude: APL, BCR-ABL1+ AML, MPAL, myeloid sarcoma, CML AP/BC, CNS leukemia, favorable-risk cytogenetics, other malignancy/residual disease, prior allo-HSCT, prior BCL2/CD47/SIRPα therapy, CYP3A inducers, treated MDS, serious organ/metabolic disease, or investigator-deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1b/2 in AML testing AK117 + azacitidine + venetoclax vs placebo + azacitidine + venetoclax. Drugs/mechanisms: • AK117: anti-CD47 monoclonal antibody (immunotherapy) that blocks the CD47–SIRPα “don’t-eat-me” signal to enhance macrophage-mediated phagocytosis of leukemia cells. • Azacitidine: hypomethylating cytidine analog (antimetabolite) that inhibits DNA methyltransferases, causing DNA hypomethylation and re-expression of silenced genes, impairing leukemic cell survival. • Venetoclax: small-molecule BH3-mimetic BCL-2 inhibitor that triggers intrinsic (mitochondrial) apoptosis. Targets/pathways: CD47 on AML blasts, SIRPα checkpoint on macrophages, DNMT-driven DNA methylation in myeloid cells, BCL-2 dependence in AML blasts/leukemic stem cells.