Phase I Trial of Lintuzumab-Ac-225, a CD33-targeted alpha emitter in AML

This Phase I study assesses the safety, tolerability, and optimal dosing of combination treatment with lintuzumab-Ac-225 (a CD33-targeted alpha emitter), venetoclax (a BCL-2 inhibitor), and ASTX-727 (a pairing of decitabine, a DNA methyltransferase inhibitor, with cedazuridine, a cytidine deaminase inhibitor) in adults with newly diagnosed AML. Participants undergo induction, re-induction, and maintenance phases with regular bone marrow and blood assessments, and the trial is sponsored by the National Cancer Institute; HMA+VEN is a standard for many unfit AML patients but often leaves MRD—adding targeted alpha therapy aims to deepen marrow clearance.