A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
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
• 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:
• 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