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NCT Number: NCT05211570

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.

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Key information

Conditions

Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia, in Relapse Bone Marrow Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities GATA2 Deficiency Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndrome Acute Myeloid Leukemia Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut Paoli Calmettes, Marseille, France

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About this study

This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome.

Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DOSE ESCALATION STUDY

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

EXPANSION COHORT STUDY

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

AB8939

Drug

Intravenous injection (from an initial dose of 0.9 mg/m²)

Venetoclax

Drug

the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.

Primary outcomes

  1. Rate of dose limiting toxicity (DLT)

    Time frame: Up to 56 days

    Identification of the Maximal Tolerated Dose for different dosing schedules

Secondary outcomes

  1. Objective Response Rate

    Time frame: Up to 56 days

    The proportion of patients who have a partial or complete response to therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Coordinator

CONTACT

[email protected]

+33(0)147200014

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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