Tests AB8939 in adults with relapsed or refractory acute myeloid leukemia
Tests the safety of daily AB8939 infusions in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- athens, Athens, and Patra, GreeceSee the 4 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) that came back or did not respond, who are at their second or third line of treatment. It tests the drug AB8939.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute myeloid leukemia at second or third line of treatment. In the dose escalation part, refractory myelodysplastic syndrome at second or third line with high prognostic risk (IPSS-R) also counts.
- Earlier treatment
- People must be at second or third line of treatment. People who can still have standard care cannot join. People who had a stem cell transplant within 100 days before the first dose cannot join.
Main reasons for not taking part
- Can still have standard care
- Can have a stem cell transplant at the time of joining
- Acute promyelocytic leukemia (M3)
- Active leukemia in the brain or spinal cord (CNS)
- Breastfeeding, or a positive pregnancy test
Read by machine on 12 November 2026.
Where in Greece
- “Attikon” University General Hospital of Athensathens, GreeceNo longer taking part
- Evaggelismos General Hospital of AthensAthens, GreeceNo longer taking part
- Laiko General Hospital of AthensAthens, GreeceNo longer taking part
- Universtiy General Hospital of PatraPatra, GreeceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AB Science
- Trial code
- NCT05211570EU 2024-516641-39-00
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous 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.
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 hematopoietic stem cell transplantation (HSCT) at the time of inclusion; Patients with HSCT within 100 days prior to the first administration of AB8939; Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion; Patients with HSCT within 100 days prior to the first administration of AB8939; Patients eligible to a standard of care; Patients diagnosed with acute promyelocytic leukemia (M3); Patients with clinically active CNS leukemia; 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; Patients eligible to a standard of care; Patients diagnosed with acute promyelocytic leukemia (M3); Patients with clinically active CNS leukemia; 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.
DOSE ESCALATION STUDY.