NCT05285813

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• AML
• MDS

Interventions

Type	Name	Description
DRUG	Vibecotamab	Given by vein (IV)
DRUG	Dexamethasone	Given by vein (IV) over about 60 minutes before the dose
DRUG	Acetaminophen	Given by mouth (PO) about 30-60 minutes before the dose
DRUG	Diphenhydramine	Given by mouth (PO) or Given by vein (IV) about 30-60 minutes before the dose

Timeline

• Start date: 2022-05-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-03-18
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study