Fate Therapeutics announces FDA acceptance of FT500 IND
Fate Therapeutics announced that the FDA has allowed its investigational new drug, or IND, Application for FT500, the company's universal, off-the-shelf natural killer, or NK, cell product candidate derived from a clonal master induced pluripotent stem cell, or iPSC, line. The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product. The company plans to initiate first-in-human clinical testing of FT500 in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This study is expected to evaluate the safety and tolerability of multiple doses of FT500, in multiple dosing cycles with nivolumab, pembrolizumab or atezolizumab, in subjects that have progressed or failed on checkpoint inhibitor therapy.