A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML
Dana-Farber Cancer Institute
Summary
The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: * Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion * CIML NK (a cellular therapy) * IL-2 (a recombinant, human glycoprotein) * Venetoclax (a selective inhibitor of BCL-2 protein)
Description
This is an open-label, single center phase I trial combining Cytokine-induced memory-like natural killer (CIML NK) cell therapy with low-dose IL-2 and with venetoclax as consolidation therapy in acute myeloid leukemia (AML). This is the first time that CIML NK cells in combination with venetoclax will be given to humans. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as a treatment for AML. The U.S. FDA has not approved IL-2 for AML but it has been approved for other uses. The U.S. FDA has approved venetoclax as a treatment option for AML. The research study pr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for Trial Enrollment (Screening Visit #1): * Diagnosis of acute myeloid leukemia (AML) * Age ≥ 18 years old * At time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle of HMA (azacitidine or decitabine) + venetoclax. Patients can have received other lines of therapy prior to HMA + venetoclax therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \> 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-…
Interventions
- BiologicalCytokine-Induced Memory-like Natural Killer Cells
Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
- BiologicalInterleukin-2
Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous (under the skin) injection per protocol.
- DrugVenetoclax
Selective inhibitor of BCL-2 protein, 10, 50, or 100 mg tablets, via orally per standard-of-care.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts