Study on AB8939 for Patients with Relapsed or Hard-to-Treat Acute Myeloid Leukemia

Sponsor: AB Science

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05211570

Provider View

This clinical trial is testing a new drug, AB8939, to see if it is safe and well-tolerated in patients with acute myeloid leukemia (AML) that has returned or is not responding to treatment. The study aims to find the best dose for future research.

Patient Parameters

Program Overview

The main goal of this study is to determine the safety and tolerability of AB8939 in patients with acute myeloid leukemia (AML) that has come back or is not responding to treatment. Researchers will identify any side effects, the highest dose patients can tolerate, and the recommended dose for further studies.

Description

This study is divided into two parts and involves patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and myelodysplastic syndrome. In the first part, researchers will gradually increase the dose of AB8939 to find the safest and most effective dose. This part will help determine how the drug is processed in the body and its side effects. In the second part, the study will expand to include more patients to further assess the drug's effectiveness and determine the best schedule for future trials. Participants will receive AB8939 through an IV and will be closely monitored for their response to the treatment and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of acute myeloid leukemia (AML) and are eligible for second or third line of treatment.
  • Have a confirmed diagnosis of hard-to-treat myelodysplastic syndrome and are at high risk based on specific scoring.
  • Be in good overall health with an ECOG performance status of 1 or less, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to understand and sign a consent form before starting the study.
  • Be willing to follow all study procedures, including bone marrow biopsies.

Exclusion Criteria

  • Eligible for standard treatment options.
  • Eligible for a stem cell transplant at the time of joining the study.
  • Diagnosed with a specific type of leukemia called acute promyelocytic leukemia (M3).
  • Have active leukemia in the central nervous system.
  • Have had a stem cell transplant within 100 days before starting the study.
  • Women who are breastfeeding or plan to breastfeed during the study.
  • Women who are pregnant or have a positive pregnancy test.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.