A Phase 2, Adaptive, Randomized, Open-label, Assessor-blinded Active-controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Standard of Care in Patients Suffering From Systemic Lupus Erythematosus (SLE) With Active, Refractory Lupus Nephritis (LN).
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN).
• Men and women with SLE, aged \>= 18 years and =\< 65 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
• Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
• Active lupus nephritis without signs of significant chronicity
• SLEDAI-2K Criteria at screening: SLEDAI-2K score \>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to fever, lupus headache, alopecia, and organic brain syndrome.
• Inadequate response at screening to at least two LN treatment regimens