eligibility_summary
Eligible: histologically confirmed AML, B-ALL, or MDS with no remaining standard options/ineligible, ≥5% blasts (or myeloblasts for MDS), CD123+ by local lab, ECOG 0-2. Exclude: CNS metastases or carcinomatous meningitis, significant cardiac disease (CHF > NYHA II, coronary disease such as unstable angina at rest, new-onset angina within 6 months, or MI within 6 months).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: VIP943, a CD123-directed antibody-drug conjugate (ADC), given IV weekly or twice weekly in dose escalation. Mechanism of action: an anti-CD123 monoclonal antibody binds IL‑3 receptor alpha (CD123) on malignant cells, is internalized, and releases a potent cytotoxic payload intracellularly via linker cleavage, causing targeted cell death of CD123+ cells. Targets: CD123/IL‑3Rα-expressing hematologic malignancies—relapsed/refractory AML, B‑ALL, and high-risk MDS—including leukemic blasts and progenitor/stem-like cells that overexpress CD123. The ADC leverages CD123 surface expression for selective delivery, it is not primarily designed to modulate IL‑3 signaling pathways but to provide targeted cytotoxicity. No other drugs are tested.