AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Last updated: September 29, 2025
Sponsor: AB Science
Overall Status: Active - Recruiting

Phase

1/2

Condition

White Cell Disorders

Leukemia

Treatment

AB8939

Venetoclax

Azacitidine

Clinical Study ID

NCT05211570
AB18001
2020-005122-28
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

DOSE ESCALATION STUDY

Key Inclusion Criteria:

  • Patients with documented diagnosis of acute myeloid leukemia (AML) based on the lastversion of the World Health Organization classification and eligible to second orthird line of treatment.

  • Patients with documented diagnosis of refractory melyodisplastic syndrome in secondor third line of treatment, and with high risk at prognosis based on the IPSS-Rscoring system.

  • ECOG performance status ≤ 1

  • Patients are able to understand, sign, and date the written informed consent form atscreening 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

Key Exclusion Criteria:

  • Patients eligible to a standard of care

  • Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time ofinclusion

  • 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 lastversion of the World Health Organization classification and eligible to second orthird line of treatment.

  • ECOG performance status ≤ 2

  • Patients are able to understand, sign, and date the written informed consent form atscreening 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 ofinclusion

  • 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

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: AB8939
Phase: 1/2
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille 2995469,
    France

    Site Not Available

  • National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit

    Athens,
    Greece

    Site Not Available

  • National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit

    Athens 264371,
    Greece

    Active - Recruiting

  • General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)

    Alicante,
    Spain

    Site Not Available

  • General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)

    Alicante 2521978,
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcantara

    Cáceres,
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Cáceres 2520611,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Quirónsalud

    Madrid,
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center Madrid

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Hospital Universitario Quirónsalud

    Madrid 3117735,
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center Madrid

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona 3114472,
    Spain

    Active - Recruiting

  • Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)

    Sevilla,
    Spain

    Site Not Available

  • Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)

    Seville 2510911,
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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