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).
Novartis Pharmaceuticals
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).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Men and women with SLE, aged \>= 18 years and =\< 75 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 chroni…
Interventions
- Biologicalrapcabtagene autoleucel
single infusion of rapcabtagene autoleucel
Locations (93)
- University Of AlabamaBirmingham, Alabama
- Loma Linda UniversitySan Bernardino, California
- UCSFSan Francisco, California
- UCSFSan Francisco, California
- Sutter Health NetworkSan Pablo, California
- Ann and Robert H Lurie Childs HospChicago, Illinois