eligibility_summary
Adults ≥18 with intermediate/high-risk MDS (WHO 2016), blasts <20% and IPSS-R >3.5, ECOG 0–2, no prior MDS anti-tumor therapy (supportive care allowed, ≥28-day washout for lenalidomide/thalidomide/ATG/cyclosporine), HSCT-eligible or -ineligible but not scheduled, survival ≥12 wks, adequate organ/labs, contraception through 6 mo post, consent and marrow sampling. Exclude AML/t-MDS/MPN/MDS-MPN, prior anti-CD47/SIRPα, transplant plans, other hemolysis, other trials, or other anti-cancer therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, open-label trial (terminated) comparing lemzoparlimab + azacitidine (AZA) versus AZA alone in treatment‑naïve higher‑risk MDS. Lemzoparlimab: fully human monoclonal antibody immunotherapy targeting CD47, blocks the CD47–SIRPα innate immune checkpoint (“don’t‑eat‑me” signal), enhancing macrophage-mediated phagocytosis of malignant myeloid cells. Azacitidine: hypomethylating agent (cytidine analog/antimetabolite), incorporates into DNA/RNA and inhibits DNA methyltransferases (DNMT), leading to DNA hypomethylation, altered gene expression, differentiation, and apoptosis. Targets/pathways: CD47 on MDS blasts/progenitors, SIRPα on macrophages, DNMT-driven epigenetic dysregulation in hematopoietic cells.