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

Ovarian Cancer Clinical Trial

Official title:
A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Combination With N-803 (Il-15 Superagonist) in Recurrent Ovarian Cancer

Clinical Trial 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 combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer (HGOC). Names of the study therapies involved in this study are: - CIML NK (cellular therapy) - N-803 (a novel immune-cell stimulator)

Clinical Trial 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 combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer. Participants will be enrolled to test the safety of CIML NK cell therapy with N-803. 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 FDA has not approved N-803 (IL-15 superagonist) 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 immunotherapy study drug (N-803), 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. Immunity Bio is supporting this study by providing N-803. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06321484
Study type Interventional
Source Dana-Farber Cancer Institute
Contact DFCI Clinical Trials Hotline
Phone 877-DF-TRIAL
Email rebecca_porter@dfci.harvard.edu
Status Not yet recruiting
Phase Phase 1
Start date May 2024
Completion date October 31, 2031
View Details
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