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AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT05211570 · AB Science
In plain English
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Official 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
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.
Eligibility criteria
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
Study design
Enrollment target: 78 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-06-01
Estimated completion: 2026-12
Last updated: 2025-10-02
Interventions
Drug: AB8939Drug: Venetoclax
Primary outcomes
- • Rate of dose limiting toxicity (DLT) (Up to 56 days)
Sponsor
AB Science · industry
Contacts & investigators
ContactClinical Study Coordinator · contact · clinical@ab-science.com · +33(0)147200014
InvestigatorNorbert Vey, MD · principal_investigator, Institut Paoli Calmettes, Marseille, France
InvestigatorNicholas Short, MD · principal_investigator, MD Anderson Cancer Center, Houston, Texas
All locations (10)
MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
Institut Paoli CalmettesNot Yet Recruiting
Marseille, France
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation UnitRecruiting
Athens, Greece
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)Recruiting
Alicante, Spain
Hospital San Pedro de AlcantaraRecruiting
Cáceres, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario QuirónsaludRecruiting
Madrid, Spain
MD Anderson Cancer Center MadridRecruiting
Madrid, Spain
Clínica Universidad de NavarraRecruiting
Pamplona, Spain
Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)Recruiting
Seville, Spain