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New hope for tough leukemia? early trial tests AB8939

NCT ID NCT05211570

Disease control Sponsor: AB Science Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called AB8939, given daily through a vein, for people with acute myeloid leukemia that has come back or not responded to standard treatments. About 78 participants will receive AB8939, sometimes with another drug called venetoclax. The main goals are to find a safe dose and see if the drug can shrink or control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AB8939 (a drug given intravenously) and venetoclax (a chemotherapy pill)
What this could lead to
If successful, this could point toward a new treatment option for people with acute myeloid leukemia that has come back or not responded to other therapies.
What could go wrong
This is an early phase 1/2 trial with only 78 participants, so it is too soon to know if AB8939 is safe or effective. The drug may cause serious side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia GATA2 Deficiency myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia refractory Acute myeloid leukemia, in relapse Myelodysplastic syndrome/acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clínica Universidad de Navarra

    RECRUITING

    Pamplona, Spain

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

    RECRUITING

    Alicante, Spain

  • Hospital San Pedro de Alcantara

    RECRUITING

    Cáceres, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Quirónsalud

    RECRUITING

    Madrid, Spain

  • Institut Paoli Calmettes

    NOT_YET_RECRUITING

    Marseille, France

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center Madrid

    RECRUITING

    Madrid, Spain

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

    RECRUITING

    Athens, Greece

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

    RECRUITING

    Seville, Spain

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