NCT06152809

CIML NK Cells With Venetoclax for AML

A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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 procedures include screening for eligibility, study treatment visits, electrocardiograms (ECGs), bone marrow biopsies, blood tests, and echocardiograms. Participants will be followed for up to 1 year after the start of therapy. It is expected that about 10 people will take part in this research study. This research is funded by the Leukemia and Lymphoma Society.

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Recurrent
• Leukemia
• Leukemia, Myeloid

Interventions

Type	Name	Description
BIOLOGICAL	Cytokine-Induced Memory-like Natural Killer Cells	Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
BIOLOGICAL	Interleukin-2	Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous (under the skin) injection per protocol.
DRUG	Venetoclax	Selective inhibitor of BCL-2 protein, 10, 50, or 100 mg tablets, via orally per standard-of-care.

Timeline

• Start date: 2024-02-20
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2023-12-01
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study