AMLPhase 2NCT05285813
A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
A Phase 2 study testing Vibecotamab, Dexamethasone and Acetaminophen in people with AML and MDS, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Vibecotamab, Dexamethasone and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to 15 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- AML MRD cohort only: AML in first or second morphologic remission (defined as complete remission [CR], complete remission with incomplete hematologic recovery [CRi], or morphologic leukemia-free state [MLFS]) who have received a minimum prior therapy with at least 1 course of intensive intermediate to high-cytarabine-based chemotherapy or at least 2 courses of lower-intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based)
- AML MRD cohort only: Persistent or recurrent MRD positivity detected by MFC at a level of ≥0.1%.
- AML MRD cohort only: For patients who are MRD positive by MFC, residual leukemia must be positive for CD123 expression at a level of at least 20% (as assessed by clinical pathologist)
- MDS post-HMA failure cohort only: MDS that is intermediate, high risk or very high risk by the Revised International Prognostic Scoring System (IPSS) or CMML-1 or CMML-2 who have not responded after at least 4 cycles of azacitidine and/or decitabine or who progressed or relapsed after azacitidine and/or decitabine, regardless of the number of cycles received
- MDS post-HMA failure cohort only: Aberrant blasts must be positive for CD123 expression by MFC at a level of at least 20% (as assessed by clinical pathologist)
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- Performance status 2 (ECOG Scale).
- Female patients of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after the last dose of vibecotamab and must also refrain from oocyte donation during this time period. Women are considered to be of childbearing potential unless it is documented that they are over the age of 60 OR postmenopausal by history with no menses for 1 year and confirmed by follicle-stimulating hormone (using local reference ranges) OR have a history of hysterectomy and/or bilateral oophorectomy OR have a history of bilateral tubal ligation. Highly effective methods of birth control include hormonal birth control (oral, intravaginal, transdermal, implantable, or intrauterine), intrauterine devices, vasectomized partner, or any double-barrier methods (combination of male condom and spermicide with either cap, diaphragm, or sponge).
- 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.
- Signed informed consent
Who cannot join
- Prior treatment with vibecotamab or anti-CD123-directed therapy.
- Clinically significant organ dysfunction, defined as:
- AST or ALT >3x the upper limit of normal (ULN)
- Total bilirubin >1.5x the ULN, unless due to ongoing hemolysis or Gilbert's syndrome
- Creatinine clearance <30 mL/min
- Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
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- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of clinical improvement despite antimicrobial treatment).
- Patients who are expected to be able to proceed with stem cell transplantation within the next 30 days
- Known human immunodeficiency virus (HIV) with detectable viral load.
- Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI
- Treatment with any antileukemic agents or chemotherapy agents in the last 7 days or 5 half-lives (whichever is sooner) before study entry
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Vibecotamab, Dexamethasone, Acetaminophen, Diphenhydramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibecotamabDrug
Also called XmAb14045
Given by vein (IV)
DexamethasoneDrug
Also called Decadron
Given by vein (IV) over about 60 minutes before the dose
AcetaminophenDrug
Also called Tylenol®, Dorcol®, Feverallâ"¢, Panadol®
Given by mouth (PO) about 30-60 minutes before the dose
DiphenhydramineDrug
Also called Benadryl®
Given by mouth (PO) or Given by vein (IV) about 30-60 minutes before the dose
| Study group | Role | What they receive |
|---|---|---|
| AML MRD cohort only | Experimental | 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. Receives: Drug: Vibecotamab; Drug: Dexamethasone; Drug: Acetaminophen; Drug: Diphenhydramine |
| MDS post-HMA failure cohort only | Experimental | 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. Receives: Drug: Vibecotamab; Drug: Dexamethasone; Drug: Acetaminophen; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start6 May 2022
- Primary completion15 May 2026
- Study completion15 May 2026
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Short, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285813
- Sponsor's protocol ID
- 2021-1124
- Other IDs
- NCI-2022-02215
- Status last verified
- May 2026
- First submitted
- 8 Mar 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Short NJ, Bataller A, DiNardo CD, Montalban-Bravo G, Wang SA, Wang W, Maiti A, Nguyen D, Hachem MC, Bi TM, Issa GC, Chien KS, Ohanian M, Kadia TM, Loghavi S, Karrar O, Bachireddy P, Hwang H, Huang X, Garcia-Manero G, Ravandi F. Vibecotamab for measurable residual disease in acute myeloid leukemia and for myelodysplastic syndromes and chronic myelomonocytic leukemia after hypomethylating agent failure: a phase II study. J Hematol Oncol. 2026 Jun 27. doi: 10.1186/s13045-026-01825-3. Online ahead of print.
PubMed 42365365
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
- ClinicalTrials.gov ID
- NCT05285813
- Acronym / sponsor ID
- 2021-1124
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 51 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AML MRD cohort only | Experimental | Drug: Vibecotamab, Drug: Dexamethasone, Drug: Acetaminophen, Drug: DiphenhydramineEach 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. |
| MDS post-HMA failure cohort only | Experimental | Drug: Vibecotamab, Drug: Dexamethasone, Drug: Acetaminophen, Drug: DiphenhydramineEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥18 years of age
- AML MRD cohort only: AML in first or second morphologic remission (defined as complete remission [CR], complete remission with incomplete hematologic recovery [CRi], or morphologic leukemia-free state [MLFS]) who have received a minimum prior therapy with at least 1 course of intensive intermediate to high-cytarabine-based chemotherapy or at least 2 courses of lower-intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based)
- AML MRD cohort only: Persistent or recurrent MRD positivity detected by MFC at a level of ≥0.1%.
- AML MRD cohort only: For patients who are MRD positive by MFC, residual leukemia must be positive for CD123 expression at a level of at least 20% (as assessed by clinical pathologist)
- MDS post-HMA failure cohort only: MDS that is intermediate, high risk or very high risk by the Revised International Prognostic Scoring System (IPSS) or CMML-1 or CMML-2 who have not responded after at least 4 cycles of azacitidine and/or decitabine or who progressed or relapsed after azacitidine and/or decitabine, regardless of the number of cycles received
Key exclusion criteria (12 listed)
- Prior treatment with vibecotamab or anti-CD123-directed therapy.
- Clinically significant organ dysfunction, defined as:
- Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of clinical improvement despite antimicrobial treatment).
- Patients who are expected to be able to proceed with stem cell transplantation within the next 30 days
- Known human immunodeficiency virus (HIV) with detectable viral load.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibecotamabAlso: XmAb14045Given by vein (IV) | Drug | AML MRD cohort only, MDS post-HMA failure cohort only |
| DexamethasoneAlso: DecadronGiven by vein (IV) over about 60 minutes before the dose | Drug | AML MRD cohort only, MDS post-HMA failure cohort only |
| AcetaminophenAlso: Tylenol®, Dorcol®, Feverallâ"¢, Panadol®Given by mouth (PO) about 30-60 minutes before the dose | Drug | AML MRD cohort only, MDS post-HMA failure cohort only |
| DiphenhydramineAlso: Benadryl®Given by mouth (PO) or Given by vein (IV) about 30-60 minutes before the dose | Drug | AML MRD cohort only, MDS post-HMA failure cohort only |
Primary outcome
To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42365365Short NJ, Bataller A, DiNardo CD, Montalban-Bravo G, Wang SA, Wang W, Maiti A, Nguyen D, Hachem MC, Bi TM, Issa GC, Chien KS, Ohanian M, Kadia TM, Loghavi S, Karrar O, Bachireddy P, Hwang H, Huang X, Garcia-Manero G, Ravandi F. Vibecotamab for measurable residual disease in acute myeloid leukemia and for myelodysplastic syndromes and chronic myelomonocytic leukemia after hypomethylating agent failure: a phase II study. J Hematol Oncol. 2026 Jun 27. doi: 10.1186/s13045-026-01825-3. Online ahead of print.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Short, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vibecotamab, Dexamethasone and Acetaminophen in people with AML and MDS, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.