Clinical Trial of PLX-R18 in Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation
In January, 2016, the U.S. Food and Drug Administration (FDA) cleared our application to begin a Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
The trial is designed as a multi-center, open-label, dose-escalating Phase I study to evaluate the safety of intramuscular injections of PLX-R18 cells in 30 subjects with incomplete hematopoietic recovery persisting for at least 6 months after HCT. The follow up period will be 12 months. The primary endpoint will be safety, and there will also be exploratory endpoints, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters. The clinical trial is planned to begin in 2016.