eligibility_summary
Inclusion: Adults ≥18 with untreated WHO-defined CD123+ AML, ineligible for induction (≥75y, ECOG 2-3, cardiac or pulmonary disease, CrCl 30-45 mL/min, or bilirubin 1.5-3x ULN), life expectancy ≥12 wks. Exclusion: prior HMA/venetoclax/chemo for AML/MDS/CMML/MPN, CAR-T or allo-HSCT, experimental therapy, other trial, MPN/CML/BCR-ABL1 or APL, autoimmune needing >10 mg steroids or steroid anticancer use, CNS AML, CrCl <30, bilirubin >3x ULN, AST/ALT >3x ULN.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b/2 single-arm trial of APVO436 plus venetoclax and azacitidine in newly diagnosed, CD123+ AML patients ineligible for intensive induction. APVO436: IV bispecific T‑cell engager antibody (CD123×CD3) that binds CD123 (IL‑3Rα) on AML blasts/leukemia stem cells and CD3 on T cells to redirect cytotoxic killing, priming doses used to mitigate CRS. Venetoclax: oral small‑molecule BCL‑2 inhibitor that restores mitochondrial apoptosis in AML cells. Azacitidine: hypomethylating nucleoside analog/DNA methyltransferase inhibitor that reduces DNA methylation, promoting differentiation and cell death. Targets/pathways: CD123+ malignant myeloid cells, T‑cell activation via CD3, BCL‑2–dependent survival signaling, and aberrant DNA methylation programs.