The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Age ≥12 to ≤70 years
Diagnosis of SLE per EULAR/ACR 2019 classification criteria
Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
Antinuclear antibody (ANA)
Evidence of inadequate organ function during the screening period
Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention