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
Single group
FT819
Biological/VaccineSingle Intravenous (IV) infusion of FT819 administered on Day 1
Complete Renal Response (CRR) at Week 26
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria: * UPCR \<0.5 g/g * Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
CRR at Week 52
Proportion of participants who achieve CRR at Week 52
CRR at Week 104
Proportion of participants who achieve CRR at Week 104
Overall Renal Response
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
PRR is defined as achievement of all of the following: * ≥50% reduction in UPCr from baseline and to \<3 g/g if baseline UPCr ≥3 g/g * eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
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