MG4101 for Refractory or Relapsed AML

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

Inclusion Criteria:

• Age between 18 to 65

• Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2

• Informed consent

• Diagnosed with acute myeloid leukemia by 2016 WHO criteria

• Failure to achieve complete remission after the second line of standard chemotherapy

• Relapse after the second line of standard chemotherapy and not eligible for the allogeneic stem cell transplantation

• Adequate major organ function

Exclusion Criteria:

• Acute promyelocytic leukemia

• Central nervous system involvement of the leukemia

• Hypersensitivity to IL-2

• Previous cell therapy

• Impaired major organ function