TherapyCells back in focus with FATE FDA-Clearance news
Fate Therapeutics announces that the FDA has cleared an investigational new drug application for FATE-NK100, the Co's first-in-class adaptive memory natural killer cell product
8:01 AM ET 3/13/17 | Briefing.com
"AML patients who relapse or are refractory to front-line therapy have very poor prognoses and very few treatment options, and we have shown that natural killer cell immunotherapy is a safe and efficacious approach to target and durably destroy leukemia cells in these patients," said Sarah Cooley, M.D., Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the clinical trial's lead investigator. "FATE-NK100 is a next-generation immunotherapy that is uniquely tailored to fully realize the anti-cancer activity of natural killer cells, and we are excited to pioneer the clinical investigation of this novel NK cell therapy."
The Company expects a first-in-human clinical trial of FATE-NK100 for advanced acute myeloid leukemia (AML) to open enrollment at the Masonic Cancer Center, University of Minnesota following approval of the Center's institutional review board.The first-in-human study will evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 in subjects with refractory or relapsed AML. Secondary and investigational endpoints will assess anti-tumor activity including rates of complete response, clearance of minimal residual disease, disease-free survival and overall survival. The clinical trial will utilize an accelerated dose escalation design, which is intended to test up to four dose levels of FATE-NK100 with one subject enrolled per dose level until a dose-limiting toxicity (DLT) is observed. The study will convert to a 3+3 design in the event a DLT is observed, and will enroll a ten subject expansion cohort at the maximum dose level.
