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Monoclonal Antibodies

MBG-453 + Azacitidine for AML

Phase 1 & 2
Waitlist Available
Led By Courtney DiNardo, 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
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-versus-host disease (GVHD)
Subject must have adequate renal function as demonstrated by a creatinine clearance of 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection
Must not have
Evidence of other clinically significant uncontrolled condition(s) including uncontrolled and/or active systemic infection (viral, bacterial or fungal), acute/chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment, systemic chronic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment, history of or current drug-induced interstitial lung disease or pneumonitis grade .2, diagnosis of another malignancy unless disease-free for at least 2 years and not needing active treatment, clinically significant abnormality of coagulation profile such as disseminated intravascular coagulation, use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment, impaired cardiac function or clinically significant cardiac disease, known hypersensitivity to azacitidine or mannitol
Prior allogeneic stem cell transplantation within 3 months of post-conditioning or on 10mg/day prednisolone for graft vs host disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to show how a specific and personalized treatment plan can help patients with acute myeloid leukemia (AML)."

Who is the study for?
This trial is for patients with Acute Myeloid Leukemia (AML) who are at risk of relapse. Specific eligibility criteria details were not provided, so it's important to consult the trial organizers for more information on who can participate.
What is being tested?
The study tests a combination of MBG-453 and Azacitidine as a treatment strategy for AML. It aims to assess how effective this tailored therapy is in preventing early relapse and managing clonal evolution in AML patients.
What are the potential side effects?
While specific side effects are not listed, treatments like MBG-453 and Azacitidine may cause immune system reactions, blood cell count changes, gastrointestinal symptoms, fatigue, or injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant, my lymphocyte count is healthy, and I don't have active GVHD.
Select...
My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.
Select...
I meet the specific criteria and have the required mutations for the AMLM26 INTERCEPT trial.
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I can care for myself and am up and about more than 50% of my waking hours.
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My liver functions within normal limits, except for conditions like Gilbert's syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had a stem cell transplant less than 3 months ago or am on prednisolone for graft vs host disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events (AEs)

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT03047993
14%
Infection
11%
Platelet count decreased
11%
Febrile neutropenia
11%
Upper respiratory infection
7%
Anemia
7%
Neoplasms benign, malignant and unspecified
7%
Cardiac Disorders, Other - Decompensated Heart Failure
7%
Intracranial hemorrhage
7%
Lung infection
7%
Death
4%
Mucositis
4%
Stroke
4%
Vascular Disorders, Other-Hematoma
4%
Wound infection
4%
Dyspnea
4%
Epistaxis
4%
Gastrointestinal Disorders, Other-Melena
4%
Hypotension
4%
Thromboembolic Event
4%
Blood and lymphatic disorders - Other, specify
4%
Non-cardiac chest pain
4%
Hypoxia
4%
White blood cell decreased
4%
Hematoma
4%
Immune System Disorders, Other
4%
Acute Kidney Injury
4%
Cholecystitis
4%
Fever
4%
Gastrointestinal Disorders-Hemorrhage
4%
Confusion
4%
Scrotal infection
4%
Fatigue
4%
Fracture
4%
General disorders and administration site conditions-Other, Neck Swelling
4%
Respiratory failure
4%
Soft tissue Infection
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Glutaminase Inhibitor CB-839, Azacitidine)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with MBG453 + AzacitidineExperimental Treatment1 Intervention
Participants will be randomized to arm

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,233 Total Patients Enrolled
Australasian Leukaemia and Lymphoma GroupOTHER
16 Previous Clinical Trials
4,298 Total Patients Enrolled
Courtney DiNardo, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
13 Previous Clinical Trials
637 Total Patients Enrolled
~8 spots leftby Jul 2026
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