eligibility_summary
Inclusion: AML or MDS‑IB2 (WHO 2022) with ELN intermediate/adverse risk, eligible for intensive chemo (CPX‑351 or 7+3) and planned allo‑HSCT. Exclusion: FLT3mut with midostaurin, planned gemtuzumab, refusal of sampling, ineligible for IC, prior AML/MDS therapy, CD47/SIRPα drugs, or excess anthracycline, major organ dysfunction, ECOG≥3, life expectancy <3 months, relapsed/refractory AML, APL, cardiopulmonary disease, uncontrolled HTN, QTc≥500, active infection (HIV/HBV/HCV), recent major surgery, CNS involvement, other active cancer, coagulopathy, pregnancy/lactation or inadequate contraception, age<18, incapacity, or recent other trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05829434 (withdrawn early for safety). Interventions: Magrolimab (Hu5F9-G4, humanized IgG4 monoclonal antibody), combined with intensive chemotherapy: 7+3 (cytarabine + daunorubicin) or CPX‑351 (Vyxeos, liposomal fixed-dose cytarabine/daunorubicin). Mechanisms of action: Magrolimab is an anti‑CD47 innate immune checkpoint inhibitor, it blocks the CD47 “don’t‑eat‑me” signal on AML/MDS cells, restoring macrophage SIRPα-mediated phagocytosis. Cytarabine is an antimetabolite (Ara‑C) that inhibits DNA synthesis, daunorubicin is an anthracycline that intercalates DNA and inhibits topoisomerase II, causing DNA damage. CPX‑351 delivers both drugs in liposomes to enhance uptake in leukemic cells. Targets: Leukemic blasts and high‑risk MDS progenitors, the CD47–SIRPα macrophage checkpoint, DNA replication and topoisomerase II in proliferating myeloid cells.