AMLPhase 1/2NCT06664879
ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial
A Phase 1/2 study testing MBG-453 + Azacitidine in people with AML, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- AML
- What is being tested?
- MBG-453 + Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 31 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets inclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol including:
- Master Protocol Inclusion Criteria listed in Master Protocol Appendix 3.0.
- the mutation/mutations specified for this treatment arm in Master Protocol Appendix 2.0 Compendium of Actionable Domains and Allocation Rules
- Meets MRD eligibility for INTERCEPT therapy based on a screening sample taken no more than 42 days prior to cycle 1 of day 1 of treatment on this treatment arm. Refer to Master Protocol Appendix 5 for the definitions of MRD progression/failure. Eligibility will be confirmed by the MRD review committee.
- ECOG 0-2
- Patients entering this arm post-allogeneic stem cell transplantation will need to have an absolute lymphocyte count of .0.2 x 109/L and no evidence of active acute graft-versushost disease (GVHD)
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- Subject must have adequate renal function as demonstrated by a creatinine clearance .
- 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection 6. Subject must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) . 3.0 ~ ULN
- alanine aminotransferase (ALT) . 3.0 ~ ULN
- bilirubin . 1.5 ~ ULN (unless bilirubin rise is due to Gilbert fs syndrome or of nonhepatic origin) 7. Agrees to follow the recommended contraception procedures for this treatment domain
Who cannot join
- Presence of any general exclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol 2. Prior allogeneic stem cell transplantation within 3 months of post-conditioning or on
- 10mg/day prednisolone for graft vs host disease 3. Subject is HIV positive 4. Patients with .5% myeloblasts in bone marrow on morphologic assessment 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Acute/Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) or resolved HBV infection may participate. 6. Systemic chronic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed. 7. For initial enrolment to INTERCEPT therapy, patients who have received previous TIM3 inhibitor treatment are excluded. This exclusion criteria does not apply to patients crossing-over from MBG453 arm to the combination MBG453 + azacitidine arm, unless MBG453 was ceased due to MBG453-related toxicity. 8. Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded 9. History of or current drug-induced interstitial lung disease or pneumonitis grade .2 10. Subject has been diagnosed with another malignancy, unless disease-free for at least 2 years and not needing active treatment. Patients with fully excised BCC/SCC/CIN or other minor malignancy are not excluded 11. Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation 12. Use of any live vaccines against infectious diseases (i.e. Influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment 13. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade . 2) with an LVEF of <40%, uncontrolled hypertension or clinically significant arrhythmia
- Acute myocardial infarction or unstable angina pectoris . 3 months prior to study entry 14. Known hypersensitivity to azacitidine or mannitol.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML.
Read the detailed description
Primary Objective:
To determine the MRD response of patients with AML to decision-rule guided therapy.
Secondary Objectives:
To determine the durability of the response of patients with AML to decision-rule guided therapy.
A key scientific objective of the study is to investigate the dynamics of MRD response and the duration of clinical benefit in the morphologic and MRD failure strata.
To investigate if duration of MRD response is longer for patients treated at MRD vs morphologic failure. Safety: To characterize the safety and tolerability of targeted therapies (as single agents and in combination with other agents).
To investigate the efficacy of distinct treatment sequences in AML patients who fail one or more lines of therapy on study.
To determine the overall efficacy of the platform as an evolving system for managing patients with AML. Quality of Life.
To investigate patterns and mechanisms of resistance.
To determine the response of patients with AML with morphologic relapse in each treatment arm.
To determine the response of patients with AML with a secondary MRD marker in each treatment arm.
- Conditions
- AML
- Being tested
- MBG-453 + Azacitidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBG-453 + AzacitidineDrug
Given intravenously (by vein)
| Study group | Role | What they receive |
|---|---|---|
| Treatment with MBG453 + Azacitidine | Experimental | Participants will be randomized to arm Receives: Drug: MBG-453 + Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 posted30 Oct 2024
- Study start30 Dec 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group
- Responsible party
- Sponsor
- Investigators
- Courtney DiNardo, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664879
- Sponsor's protocol ID
- 2021-1117
- Other IDs
- NCI-2024-10306
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial
- ClinicalTrials.gov ID
- NCT06664879
- Acronym / sponsor ID
- 2021-1117
- Conditions
- AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 30 Oct 2024 (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.
To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML.
Detailed description
Primary Objective:
To determine the MRD response of patients with AML to decision-rule guided therapy.
Secondary Objectives:
To determine the durability of the response of patients with AML to decision-rule guided therapy.
A key scientific objective of the study is to investigate the dynamics of MRD response and the duration of clinical benefit in the morphologic and MRD failure strata.
To investigate if duration of MRD response is longer for patients treated at MRD vs morphologic failure. Safety: To characterize the safety and tolerability of targeted therapies (as single agents and in combination with other agents).
To investigate the efficacy of distinct treatment sequences in AML patients who fail one or more lines of therapy on study.
To determine the overall efficacy of the platform as an evolving system for managing patients with AML. Quality of Life.
To investigate patterns and mechanisms of resistance.
To determine the response of patients with AML with morphologic relapse in each treatment arm.
To determine the response of patients with AML with a secondary MRD marker in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with MBG453 + Azacitidine | Experimental | Drug: MBG-453 + AzacitidineParticipants will be randomized to arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Meets inclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol including:
- Meets MRD eligibility for INTERCEPT therapy based on a screening sample taken no more than 42 days prior to cycle 1 of day 1 of treatment on this treatment arm. Refer to Master Protocol Appendix 5 for the definitions of MRD progression/failure. Eligibility will be confirmed by the MRD review committee.
- ECOG 0-2
- Patients entering this arm post-allogeneic stem cell transplantation will need to have an absolute lymphocyte count of .0.2 x 109/L and no evidence of active acute graft-versushost disease (GVHD)
- Subject must have adequate renal function as demonstrated by a creatinine clearance .
Key exclusion criteria (6 listed)
- Presence of any general exclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol 2. Prior allogeneic stem cell transplantation within 3 months of post-conditioning or on
- 10mg/day prednisolone for graft vs host disease 3. Subject is HIV positive 4. Patients with .5% myeloblasts in bone marrow on morphologic assessment 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade . 2) with an LVEF of <40%, uncontrolled hypertension or clinically significant arrhythmia
- Acute myocardial infarction or unstable angina pectoris . 3 months prior to study entry 14. Known hypersensitivity to azacitidine or mannitol.
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 |
|---|---|---|
| MBG-453 + AzacitidineGiven intravenously (by vein) | Drug | Treatment with MBG453 + Azacitidine |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Courtney DiNardo, 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 1/2 study testing MBG-453 + Azacitidine in people with AML, 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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.