CIML-NK Cells

The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product. At the time of infusion, the product is comprised of: * Cytokine-Induced Memory-Like NK cells (CIML-NK cells) * Human Serum Albumin * Plasmalyte The concentration and total cell number of CIML-NK cells in the product will vary based on the recipient body weight and the dose requested.

The goal of treatment of relapsed or refractory acute myeloid leukemia (AML) is to achieve remission and proceed to hematopoietic stem cell transplant (HSCT). Unfortunately, standard protocols have limited success. In this study the investigators will identify patients with relapsed or refractory AML who are unlikely to benefit from standard chemotherapy protocols and do not qualify for, or do not wish to participate in, institutional chemotherapy trials.

Peripheral blood from a related haploidentical donor will be collected for the isolation of natural killer (NK) cells. NK cells will be induced into a memory-like state using cytokine supplementation only. In this Phase I/II study, Patients will receive a lymphodepleting chemotherapy regimen, after which the cytokine-induced memory-like NK cells (CIML-NKs) will be infused. The primary study endpoint is the feasibility and safety of infusion of the cells.

The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.

Registro actualizado en ClinicalTrials.gov →

• Of age ≥ 2 years of age at the time of study enrollment
• With AML diagnosed per 2016 WHO criteria (11)
• With relapsed or refractory AML in their bone marrow
• Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment
• Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR
• With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.