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).
Additional locations may be listed on ClinicalTrials.gov for NCT06581198.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Name Not Available
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.
Lead OrganizationNovartis Pharmaceuticals Corporation
