drugset / Trial / NCT03349502

MG4101 for Refractory or Relapsed AML

NCT03349502

Phase 2 Completed 11 enrolled Seoul National University Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a single center, single arm, open-labeled phase 2 clinical study. The aim of this study is to investigate the efficacy and safety of allogeneic natural killer cell (MG4101). After lymphodepletion with fludarabine and cyclophosphamide, the patient will receive MG4101. Each cycle consists of 28 days, and a total of 2 cycles of MG4101 will be administered with IL-2 to activate the study drug. The efficacy of MG4101 will be evaluated after 8 weeks from the first day of treatment. We will evaluate the safety of the drug measuring the vital sign, laboratory tests, and adverse events.

Timeline

Start
2017-11-01
Primary completion
2020-03-30
Completion
2020-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MG4101 Cell therapy 2e+09 cells Intravenous
Subject MG4101 Cell therapy 3e+09 cells Intravenous
Subject MG4101 Cell therapy 4e+09 cells Intravenous
Subject MG4101 Cell therapy 5e+09 cells Intravenous