Phase 1B2A Study of Nadunolimab Combined With Azacitidine, With or Without Venetoclax, for Treating Myelodysplastic Syndrome and Acute Myelogenous Leukemia

What this Trial Is About

Researchers are evaluating the safety and optimal dosing of nadunolimab, an IL1RAP antibody, combined with azacitidine, with or without venetoclax, in patients with high-risk Myelodysplastic Syndrome MDS and relapsed or refractory Acute Myelogenous Leukemia AML. The study aims to target leukemia stem and progenitor cells to explore this treatment strategys early safety and effectiveness. This Phase 1B2A trial includes patients untreated or with limited prior therapies for MDS and those receiving salvage therapy for AML. Participants receive nadunolimab intravenously, combined with azacitidine also given intravenously. In some cases, venetoclax is added and taken by mouth. The trial has two main arms one for patients with intermediate to very high-risk MDS and another for relapsed or refractory AML patients. Treatment cycles continue up to 24 cycles depending on response, with adjustments based on patient outcomes. The trial also explores biomarkers, gene analysis, and drug exposure to better understand treatment effects. During the study, participants undergo safety monitoring for adverse events, laboratory tests to assess blood counts and organ function, and evaluations of response to treatment using established leukemia criteria within six treatment cycles. Researchers also assess duration of response and collect samples for biomarker and genetic analysis. The trial involves regular visits for treatment administration and ongoing assessments, with an average participation duration of about one year to monitor safety and early efficacy.

A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)