MedTrace Logo

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT05211570 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-10-02

No results posted yet for this 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.

Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse
  • Myelodysplastic Syndrome Acute Myeloid Leukemia

Interventions

DRUG

AB8939

Intravenous injection (from an initial dose of 0.9 mg/m²)

DRUG

Venetoclax

the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Norbert Vey, MD · Institut Paoli Calmettes, Marseille, France

  • Nicholas Short, MD · MD Anderson Cancer Center, Houston, Texas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Greece
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211570 on ClinicalTrials.gov