A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer
Dana-Farber Cancer Institute
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)
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, lymphodepleti…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma. * Participants must have measurable cancer defined by RECIST 1.1 criteria. See Section 12 (Measurement of Effect) for the evaluation of measurable disease. * Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant/intolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must ha…
Interventions
- BiologicalCytokine-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.
- DrugInterleukin 2
Low dose subcutaneous IL-2 will be administered every other day for 5 doses after CIML NK cell infusion
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts