eligibility_summary
Adults 18–75 with AML (ELN high-risk) or MDS (IPSS Int-2 poor-risk) or MRD+/<10% blasts, planned 1st/2nd reduced-intensity allo-HCT (any donor/source). ECOG ≤2, adequate counts/organ function (ANC ≥1.5, Plt ≥50K, bili/AST/ALT ≤1.5×ULN, CrCl ≥60, LVEF ≥45, PFTs ≥50% or O2>92%), consent/tissue, contraception, prior anti-CD47/HMA allowed if no progression. Exclude: >2 prior HCTs, drug allergy, pregnancy/breastfeeding, bleeding/CNS MDS, major comorbidity, active HBV/HCV/HIV, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 (withdrawn) single-arm maintenance study after allogeneic HCT for high-risk AML/MDS testing: 1) Magrolimab (Hu5F9-G4), an intravenous anti-CD47 IgG4 monoclonal antibody that blocks the CD47–SIRPα “don’t eat me” innate immune checkpoint on tumor cells, enhancing macrophage-mediated phagocytosis and potentially graft-versus-leukemia. 2) Azacitidine, an intravenous hypomethylating nucleoside analog (DNA methyltransferase inhibitor) that incorporates into DNA/RNA, causes hypomethylation, cytotoxicity, and immunogenic reprogramming of leukemic cells. Targets/pathways: CD47 on AML/MDS blasts and MRD, macrophage/SIRPα checkpoint, innate immunity, epigenetic DNA methylation pathways, with exploratory assessment of GVHD biomarkers and immune recovery.