eligibility_summary
Key eligibility: untreated MDS (WHO 2016, <20% blasts), IPSS-R >=3.5, ECOG 0-2, life expectancy >=3 mo, HSCT-eligible without a scheduled transplant or HSCT-ineligible, ABO/Rh typed, Hb >=9 g/dL (transfusions OK), WBC <=20 K/uL (hydroxyurea allowed). Exclude uncontrolled HBV/HCV/HIV, serious comorbidities, bleeding disorders, other active malignancy, immediate allo-SCT or prior HMA/chemo/SCT, therapy-related or MDS/MPN, anti-CD47, recent SCT/GVHD, study-drug allergy, CNS disease, pregnancy, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm study in previously untreated intermediate–very high-risk MDS tested oral decitabine/cedazuridine (ASTX727/INQOVI) plus magrolimab. Decitabine is a DNA hypomethylating nucleoside analog (DNMT inhibitor) that incorporates into DNA, depletes DNMT1, and hypomethylates to re-express silenced genes, promoting differentiation/apoptosis of dysplastic myeloid precursors, cedazuridine is a cytidine deaminase inhibitor that increases oral decitabine bioavailability. Magrolimab (Hu5F9‑G4) is a humanized IgG4 monoclonal antibody against CD47 that blocks the CD47–SIRPα “don’t‑eat‑me” signal, enhancing macrophage-mediated phagocytosis of malignant myeloid cells. Targets: MDS blasts/progenitors, epigenetic DNA methylation, innate immune checkpoint CD47–SIRPα (with RBC CD47 implications).