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Monoclonal Antibodies

Vibecotamab for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Nicholas Short, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status 2 (ECOG Scale)
Male patients and their female partner of childbearing potential must agree to use highly effective contraception, as above, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of vibecotamab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test a new cancer drug, vibecotamab, to see if it is safe and effective in patients with leukemia or myelodysplastic syndrome.

Who is the study for?
Adults over 18 with Acute Myeloid Leukemia (AML) in remission but still showing signs of disease, or Myelodysplastic Syndrome (MDS) unresponsive to prior treatments. Participants must have a certain level of CD123 expression on cancer cells and be able to perform daily activities with some limitations. Women who can bear children and men must use effective birth control.Check my eligibility
What is being tested?
The trial is testing vibecotamab, an antibody targeting leukemia cells, along with supportive medications like dexamethasone, acetaminophen, and diphenhydramine for safety and effectiveness in AML patients with residual disease and MDS patients after treatment failure.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drug, such as fever or chills during infusion. Other common side effects may involve fatigue, headache, nausea, or allergic reactions due to the medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk and care for myself but cannot do any physical work.
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My partner and I agree to use effective birth control and I won't donate sperm while on vibecotamab and for 4 weeks after.
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My leukemia cells show at least 20% CD123 expression.
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I am 18 years old or older.
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My AML is in remission after intensive chemotherapy.
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My MDS is high risk and didn't improve after 4+ cycles of specific treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: MDS post-HMA failure cohort onlyExperimental Treatment4 Interventions
Each study cycle is 28 days. Vibecotamab by vein (IV) over about 2 hours On Days 1, 3, 5, 8, 15 and 22 of Cycle 1 and then on Days 1, 8, 15 and 22 of Cycles 2-4.
Group II: AML MRD cohort onlyExperimental Treatment4 Interventions
Each study cycle is 28 days. Vibecotamab by vein (IV) over about 2 hours On Days 1, 3, 5, 8, 15 and 22 of Cycle 1 and then on Days 1, 8, 15 and 22 of Cycles 2-4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Acetaminophen
2017
Completed Phase 4
~2030
Diphenhydramine
2002
Completed Phase 4
~1170

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,323 Total Patients Enrolled
Nicholas Short, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
322 Total Patients Enrolled

Media Library

Vibecotamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05285813 — Phase 2
Acute Myeloid Leukemia Research Study Groups: AML MRD cohort only, MDS post-HMA failure cohort only
Acute Myeloid Leukemia Clinical Trial 2023: Vibecotamab Highlights & Side Effects. Trial Name: NCT05285813 — Phase 2
Vibecotamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285813 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Vibecotamab obtained regulatory clearance from the Food and Drug Administration?

"Vibecotamab's safety is rated a 2 because there exist pre-clinical data supporting its security, yet no evidence to suggest that it works in this capacity."

Answered by AI

Are there any vacancies left in this healthcare experiment?

"As indicated by clinicaltrials.gov, this medical trial is actively enrolling participants. The listing was first published on May 6th 2022 and edited as recently as September 29th of the same year."

Answered by AI

What is the upper limit of patients enrolled in this medical experiment?

"Affirmative. According to the clinicaltrials.gov platform, this study has been opened for recruitment since May 6th 2022 and recently updated on September 29th of the same year. 40 participants are needed from a single medical centre."

Answered by AI
~25 spots leftby Dec 2026