Natural Killer cel therapie tegen teruggekeerde eierstokkanker.

This study is a phase I safety and feasibility study in a series of 12 patients who are suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Prior to NK cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. The first cohort of three patients will receive an intraperitoneal infusion of between 1.5x 109 and 3x109 allogeneic UCB-NK cells generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic UCB unit without a preparative regimen. In the second group of three patients the same UCB-NK cell dosage will be given with a preparative regimen of four days non-myeloablative immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (CyFlu). If no severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be included to answer the secondary objective. The primary aim of our study is to evaluate safety and toxicity of intraperitoneal infusion of ex vivo-expanded NK cells from CD34+ umbilical cord blood (UCB) progenitor cells with and without a preceding non-myeloablative immunosuppressive conditioning regimen in patients suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Secondary objectives are to compare the in vivo lifespan, expansion and biological activity of intraperitoneal infused NK cell products with and without preparative chemotherapy, and effects on disease.

Natural killer cells are cells of the innate immunesystem and can kill tumor cells without prior sensitization. By infusing these cells through a catheter in the intraperitoneal cavity, ovarian carcinoma cells can be traced and killed. This phase 1 study is designed to look at the safety and toxicity.

Trial will start including on 1st of march 2018.

Intraperitoneal natural killer cell therapy with and without preconditioning chemotherapy regimen.