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Protein Degrader

AB8939 for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Norbert Vey, MD
Research Sponsored by AB Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment
ECOG performance status ≤ 1
Must not have
Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
Women with a positive pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 days
Awards & highlights

Summary

This trial tests AB8939, a new drug, for safety and effectiveness in patients with certain blood cancers that haven't responded to other treatments. The study will determine the best dose and schedule for future trials.

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia or high-risk Myelodysplastic Syndromes who've had previous treatments fail. They must be in good physical condition (ECOG ≤ 1), able to consent, and follow study procedures like bone marrow biopsies. It's not for those eligible for standard care, stem cell transplant, have certain leukemia types or CNS involvement, recent transplants, or are pregnant/breastfeeding.
What is being tested?
The trial tests AB8939's safety and tolerability in patients with AML by finding the highest dose they can take without serious side effects. Participants will also receive Azacitidine as part of the treatment regimen.
What are the potential side effects?
Specific side effects aren't listed but generally include reactions related to drug tolerance levels such as fatigue, nausea, blood count changes, and potential organ-specific toxicity which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have acute myeloid leukemia and need second or third line treatment.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have a high-risk myelodysplastic syndrome not responding to first treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am eligible for a stem cell transplant.
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I am currently pregnant.
Select...
I have active leukemia in my brain or spinal cord.
Select...
I have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of dose limiting toxicity (DLT)
Secondary study objectives
Objective Response Rate

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)

Trial Design

2Treatment groups
Experimental Treatment
Group I: AB8939 plus azacitidineExperimental Treatment2 Interventions
AB8939 administered in combination with azacitidine
Group II: AB8939Experimental Treatment1 Intervention
AB8939 administered as a single agent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Myelogenous Leukemia (AML) include cytotoxic therapies like cytarabine and daunorubicin, which disrupt DNA synthesis and function, leading to cell death. These treatments target rapidly dividing cells, including cancerous ones. Targeted therapies, such as FLT3 and IDH inhibitors, focus on specific genetic mutations or abnormal proteins that drive AML cell growth. These therapies aim to minimize damage to normal cells while effectively targeting cancer cells. Understanding these mechanisms helps in selecting the most appropriate treatment, potentially improving outcomes and reducing side effects for AML patients.

Find a Location

Who is running the clinical trial?

AB ScienceLead Sponsor
38 Previous Clinical Trials
15,644 Total Patients Enrolled
Norbert Vey, MDPrincipal InvestigatorInstitut Paoli Calmettes, Marseille, France
7 Previous Clinical Trials
710 Total Patients Enrolled
Nicholas Short, MDPrincipal InvestigatorMD Anderson Cancer Center, Houston, Texas
6 Previous Clinical Trials
280 Total Patients Enrolled
~5 spots leftby Dec 2024
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