ClinicalTrials.gov ID NCT06321484
Sponsor Dana-Farber Cancer Institute
Information provided by Rebecca Porter, MD, PhD, Dana-Farber Cancer Institute (Responsible Party)
Last Update Posted 2024-11-01
Study Overview
Brief 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.