NCT06581198

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Conditions

• Lupus Erythematosus, Systemic
• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	rapcabtagene autoleucel	single infusion of rapcabtagene autoleucel

Timeline

• Start date: 2024-09-04
• Primary completion: 2028-02-14
• Completion: 2032-02-06
• First posted: 2024-09-03
• Last updated: 2026-02-20

Locations

93 sites across 23 countries: United States, Australia, Austria, Brazil, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Norway, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study