The IND has been allowed by the FDA, and the company is currently conducting trial start-up activities at multiple clinical sites. The PhI is designed to assess a three-dose schedule of FT522 in each of two regimens:
Regimen A - Up to two treatment cycles, with each treatment cycle consisting of conditioning chemotherapy, a single dose of rituximab, and three doses of FT522.
Regimen B - Up to two treatment cycles, with each treatment cycle consisting of a single dose of rituximab and three doses of FT522 (without LD chemo).
Patient enrollment into Regimen A will commence utilising a three-dose schedule of FT522 at 300 million cells per dose. Subject to clearance of dose-limiting toxicities at this initial dose level of Regimen A, patient enrollment into Regimen B will then commence utilising a three-dose schedule of FT522 at 300 million cells per dose. Dose escalation of each regimen may proceed independently.