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).
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).
This is a Phase 2, adaptive, five-year, randomized, assessor-blinded, active controlled study:
- Part A: Participants suffering from systemic lupus erythematosus (SLE) with active, refractory LN will be randomized to Regimen 1, Regimen 2, or SOC.
- Part B: Participants suffering from SLE with active, refractory LN will be randomized to the selected regimen from Part A or SOC.
The study will consist of two periods:
- A screening period lasting up to 6 weeks, and
- A randomized treatment period and primary follow-up period lasting up to 5 years.
Participants in the SoC arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible.