Clinical trial · Interventional
MG4101 for Refractory or Relapsed AML
Pilot Study of Safety and Efficacy of Lymphodepletion Followed by MG4101 Administered Intravenously to Patients With Refractory or Relapsed AML
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MG4101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MG4101
- description
- 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
- interventionNames
- Drug: MG4101
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- After completion of 2 cycles of treatment (Day 56 from the initiation of the treatment)
- description
- 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)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available