drugset / Trial / NCT04354025
Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patents With Refractory or Relapsed AML
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase 2 clinical trial investigates the effectiveness of cytokine-induced memory-like natural killer (CIML NK) cells in combination with FLAG chemotherapy as a treatment for refractory or relapsed AML. Previous studies in adults with AML sowed successful induction of remission and a previous phase 1 study demonstrated that CIML NK cells can be used safely in pediatric patients. This phase 2 study uses FLAG chemotherapy to lower leukemic burden and suppress the recipient's immune system to provide an optimal environment for CIML NK cell expansion and anti-leukemic activity.
Timeline
- Start
- 2023-06-30
- Primary completion
- 2026-09-30
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CIML-NK Cells | Cell therapy | 500000 cells/kg | — |
| Subject | CIML-NK Cells | Cell therapy | 1e+07 cells/kg | — |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | G-CSF | Unknown | 5 ug/kg | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | 1e+06 unknown | Subcutaneous |