FT819 with BendamustineA Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis

INCLUSION CRITERIA:

• 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
• Positivity for at least one of the following autoantibodies at screening:

1. Antinuclear antibody (ANA)
2. Anti-double-stranded DNA (anti-dsDNA) or
3. Anti-Smith antibody

• Active disease, defined as:

a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible

• Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN

EXCLUSION CRITERIA:

• 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
• Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
• History of malignancy in the prior 5 years
• Known allergy to the following FT819 components: albumin (human) or DMSO
• History of intolerance or contraindication to bendamustine
• Body weight <30 kg
• Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results