NCT06321484

Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer

A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC). Names of the study therapies involved in this study are: CIML NK (cellular therapy) Interleukin-2 (IL-2)

Detailed description

This is an open-label, single site, phase 1b study to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer. Participants will be enrolled to test the safety of intraperitoneal CIML NK cell therapy The U.S. Food and Drug Administration (FDA) has not approved CIML NK cell therapy as a treatment for recurrent, high grade ovarian cancer. The research study procedures include screening for eligibility, collection of natural killer (NK) cells in a process called leukapheresis, lymphodepleting chemotherapy, infusion of CIML NK cell therapy into the abdominal cavity (intraperitoneal), administration of low-dose IL-2, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET) scans, blood tests, urine tests, electrocardiograms (ECGs), and echocardiograms. Participants in this research study will be followed for up to for 5 years after start of study treatment. It is expected that about 12-18 people will take part in this research study. The PHASE ONE Foundation Community Research Grant is providing funding for this research study.

Conditions

• Platinum-resistant Ovarian Cancer
• Recurrent Ovary Cancer
• Ovarian Cancer
• Ovarian Carcinoma
• Ovarian Carcinoma, Recurrent
• Endometroid Ovarian Carcinoma
• Clear Cell Ovarian Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cytokine-Induced Memory-like Natural Killer Cells	Cytokine Induced Memory-like Natural Killer (CIML NK) Cells Autologous, cytokine induced memory-like natural killer cells, via intraperitoneal (IP) infusion per protocol.
DRUG	Interleukin 2	Low dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-11-30
• Completion: 2031-10-31
• First posted: 2024-03-20
• Last updated: 2026-03-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study