Actively Recruiting
Phase 2 Study of Rapcabtagene Autoleucel to Treat Active, Refractory Systemic Lupus Erythematosus or Lupus Nephritis in Adults
Led by Novartis Pharmaceuticals · Updated on 2026-06-03
179
Participants Needed
101
Research Sites
207 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of rapcabtagene autoleucel in adults with active, treatment-resistant systemic lupus erythematosus SLE or lupus nephritis LN. This phase 2, open-label study focuses on patients who have not responded adequately to at least two prior therapies and meet specific criteria for disease activity and antibody presence. Participants will receive a single infusion of rapcabtagene autoleucel after lymphodepletion. The study includes monitoring at weeks 24 and 52 to assess how well the treatment works. This approach aims to understand if this biological therapy can improve lupus symptoms and kidney involvement. During the trial, participants will undergo regular evaluations including disease activity scores, kidney response, flare frequency, corticosteroid use, serological status, and fatigue levels. Researchers will closely monitor safety and long-term effects up to week 76, with follow-up visits to assess treatment durability and participant well-being.
CONDITIONS
Brief Title
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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