Study of GDX012 in Patients With MRD Positive AML

Summary

The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry. The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.

Timeline

Start

2021-08-13

Primary completion

2022-06-03

Completion

2022-06-03

Outcome

Outcome not reported

Stopped (Business): “This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.”

Drugs

Indications