AB8939 treatment for patients with relapsed or refractory acute myeloid leukemia
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
PHASE1; PHASE2 · AB Science · NCT05211570
This study is testing a new treatment called AB8939 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia feel better and improve their condition.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AB Science (industry) |
| Locations | 10 sites (Houston, Texas and 9 other locations) |
| Trial ID | NCT05211570 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of AB8939 in patients with relapsed or refractory acute myeloid leukemia (AML) and refractory myelodysplastic syndrome. It consists of a two-part design, starting with a dose escalation phase to identify the maximum tolerated dose and dose-limiting toxicities. Following this, a dose expansion phase will assess the treatment's efficacy and establish a schedule for a Phase 2 trial. The study is open-label and non-randomized, conducted across multiple centers.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed or refractory AML or refractory myelodysplastic syndrome who have exhausted standard treatment options.
Not a fit: Patients who are eligible for standard care or hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of AML.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment and its methodology are being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 9 other locations
- MD Anderson Cancer Center — Houston, Texas, United States (NOT_YET_RECRUITING)
- Institut Paoli Calmettes — Marseille, France (NOT_YET_RECRUITING)
- National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit — Athens, Greece (RECRUITING)
- General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante) — Alicante, Spain (RECRUITING)
- Hospital San Pedro de Alcantara — Cáceres, Spain (RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- Hospital Universitario Quirónsalud — Madrid, Spain (RECRUITING)
- MD Anderson Cancer Center Madrid — Madrid, Spain (RECRUITING)
- Clínica Universidad de Navarra — Pamplona, Spain (RECRUITING)
- Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) — Seville, Spain (RECRUITING)
Study contacts
- Principal investigator: Norbert Vey, MD — Institut Paoli Calmettes, Marseille, France
- Study coordinator: Clinical Study Coordinator
- Email: clinical@ab-science.com
- Phone: +33(0)147200014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia