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Clinical Trial 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


Clinical Trial Description

Primary Objectives: - AML MRD cohort: To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD - MDS post-HMA cohort: To determine the response rate (defined as CR + marrow CR [mCR] + partial remission [PR] + hematologic improvement [HI]) after 4 cycles of vibecotamab in patients with MDS after HMA failure Secondary Objectives: - To assess other efficacy endpoints, including remission duration, duration of MRD response (AML MRD arm only), CR rate (MDS arm only), relapse-free survival, overall survival - To assess the safety of vibecotamab in patients with AML with MRD and in patients with MDS post-HMA failure Exploratory Objectives: - To correlate clinical outcomes with CD123 expression - To determine the CD123 expression in patients who relapse after vibecotamab therapy ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05285813
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Nicholas Short, MD
Phone (713) 563-4485
Email nshort@mdanderson.org
Status Recruiting
Phase Phase 2
Start date May 6, 2022
Completion date December 31, 2026

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