drugset / Trial / NCT05285813

A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure

NCT05285813

Phase 2 Terminated 51 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II single-center study to evaluate the safety and effectiveness of vibecotamab, a CD3-CD123 bispecific antibody, in patients with acute myeloid leukemia with persistent or recurrent measurable residual disease and in patients with myelodysplastic syndrome that has not responded to or relapsed after conventional therapy

Timeline

Start
2022-05-06
Primary completion
2026-05-15
Completion
2026-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Vibecotamab Monoclonal antibody 1.7 ug/kg
Background Acetaminophen Small molecule Oral
Background Dexamethasone Small molecule Intravenous
Background Diphenhydramine Unknown Oral