MG4101 for Refractory or Relapsed AML

NCT03349502 | Completed Phase 2

• 1 other identifier: H-1705-065-853
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Allogeneic natural killer cell, MG4101

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Sum of complete remission (less than 5% of blast in normocellular or hypercellular bone marrow, no remnant leukemic cell or chloroma, absolute neutrophile count more than 1x10\^9/L, platelet count more than 100x10\^9/L) and complete remission with incomplete blood count recovery (less than 5% of blast in normocellular or hypercellular bone marrow with acute neutrophil count less than 1x10\^9/L or platelet count less than 100x10\^9/L)

  After completion of 2 cycles of treatment (Day 56 from the initiation of the treatment)

Secondary Outcomes (2)

• Overall survival

  At the end of the study (Day 112 from the initiation of the treatment)

• Duration of complete remission

  At the end of the study treatment (Day 112 from the initiation of the treatment)

Study Arms (1)

MG4101

EXPERIMENTAL

MG4101 administration (Not yet commercialized) 1. Dosage Bwt\<50 : 2.0 x109 cells (2 bags) 50≤Bwt\<70 : 3.0 x109 cells (3 bags) 70≤Bwt\<100 : 4.0 x109 cells (4 bags) Bwt≥100 : 5.0 x109 cells (5 bags) 2. Duration and frequency * Intravenous over 1 hour * Day 4, Day 11, Day 18 of each cycle

Drug: MG4101

Interventions

MG4101 DRUG

Administration of study drug (MG4101) for the patients with refractory or relapsed acute myeloid leukemia (Single arm)

Also known as: Allogeneic natural killer cell

MG4101

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute promyelocytic leukemia
• Central nervous system involvement of the leukemia
• Hypersensitivity to IL-2
• Previous cell therapy
• Impaired major organ function

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Youngil Koh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single center, single arm, open-labeled phase 2 trial

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: November 1, 2017
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)