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

NCT05285813 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nicholas Short, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2026-05-15
Completion
2026-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285813 on ClinicalTrials.gov