eligibility_summary
Eligible: adults ≥18 with newly diagnosed AML unfit for intensive chemo (age ≥75, ECOG 2–3, or cardiac/pulmonary/hepatic/renal comorbidities/other) or untreated higher‑risk MDS (IPSS‑R int/high/very high), expansion: AML relapsed/refractory to VEN+HMA after ≥2 cycles. ECOG 0–2 if ≥75, 0–3 if <75. WBC ≤20k (cytoreduction allowed), Hgb ≥9 (transfusions ok). Exclude: prior CD47/SIRPα, TIM‑3, recent ICIs/vaccines, prior antineoplastics, APL, bleeding disorders, CNS leukemia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05367401 tests: (1) Sabatolimab (MBG453), an anti–TIM-3 IgG4 monoclonal antibody checkpoint inhibitor that blocks TIM-3 on exhausted T cells/NK cells and on AML/MDS blasts and leukemic stem cells to restore antitumor immunity and potentially directly impact leukemic cells, (2) Magrolimab, an anti-CD47 IgG4 monoclonal antibody that blocks the CD47–SIRPα “don’t-eat-me” signal to promote macrophage phagocytosis of malignant myeloid cells, (3) Azacitidine, a hypomethylating cytidine analog (DNMT inhibitor) causing DNA hypomethylation and immunogenic reprogramming. Targets/pathways: TIM-3 checkpoint, CD47/SIRPα macrophage checkpoint, and aberrant DNA methylation in myeloid precursors/blasts and leukemic stem cells. Indications: 1L unfit AML, 1L higher-risk MDS, and R/R AML post VEN+HMA.