Clinical EfficacyEarly efficacy data for FT819 in 5 patients are very encouraging, especially given its off-the-shelf nature and reduced conditioning differentiation.
Regulatory ProgressFate plans to meet with the FDA to discuss potential pivotal study design in SLE/LN, aiming to remove the current hospitalization requirement post-treatment.
Safety ProfileFT819 was well-tolerated with no events of ICANS, GvHD or FT819-related SAEs, with all patients discharged 3-days post-dosing.