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AB8939 for Relapsed/Refractory Acute Myeloid Leukemia

This study is testing a new drug called AB8939, given by IV injection, in people with acute myeloid leukemia (AML) that has come back (relapsed) or isn't responding to treatment (refractory). It also includes people with refractory myelodysplastic syndrome (a bone marrow disorder that can turn into AML). The main goal is to find a safe dose of AB8939 and understand its side effects. Some participants may also receive Venetoclax, another medication for AML. The study aims to enroll 78 participants aged 18 and older. The current status of the study is unclear.

Study design
This is a Phase 1/2, open-label (meaning you and your doctors will know what treatment you are receiving), multi-center study. It is not randomized and will involve up to 78 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for up to 56 days.

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NCT05211570

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
AB Science
~78 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:AB8939Venetoclax

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of dose limiting toxicity (DLT)
Measured over Up to 56 days

Conditions

Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia, in Relapse
Myelodysplastic Syndrome Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

10 sites across 4 states
Spain7
Texas1
France1
Greece1

Study leadership

  • Norbert Vey, MD · PRINCIPAL_INVESTIGATOR · Institut Paoli Calmettes, Marseille, France
  • Nicholas Short, MD · PRINCIPAL_INVESTIGATOR · MD Anderson Cancer Center, Houston, Texas

Who to contact

Clinical Study Coordinator
[email protected]
+33(0)147200014
Email the study team

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Eligibility criteria

Inclusion

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.
Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
ECOG performance status ≤ 1
Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
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 ≤ 2
Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies

Exclusion

Patients eligible to a standard of care
Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
Patients diagnosed with acute promyelocytic leukemia (M3)
Patients with clinically active CNS leukemia
Patients with HSCT within 100 days prior to the first administration of AB8939
Women who are lactating/breastfeeding or who plan to breastfeed while on study
Women with a positive pregnancy test
Patients eligible to a standard of care
Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
Patients diagnosed with acute promyelocytic leukemia (M3)
Patients with clinically active CNS leukemia
Patients with HSCT within 100 days prior to the first administration of AB8939
Women who are lactating/breastfeeding or who plan to breastfeed while on study
Women with a positive pregnancy test

What this trial measures

  • Rate of dose limiting toxicity (DLT)Up to 56 days

    Identification of the Maximal Tolerated Dose for different dosing schedules