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

Korábbi kezelés

• Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention

Más betegség

• 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
• 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
• History of intolerance or contraindication to bendamustine

Laborértékek

• Known allergy to the following FT819 components: albumin (human) or DMSO
• 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

Egyéb

• Evidence of inadequate organ function during the screening period
• Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
• Body weight \<30 kg

• 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:
  • Antinuclear antibody (ANA)
  • Anti-double-stranded DNA (anti-dsDNA) or
  • Anti-Smith antibody
• Active disease, defined as:
  • 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