A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 chronicity or active systemic lupus erythematosus - SLEDAI-2K Criteria at screening: SLEDAI-2K score >= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome". - Inadequate response at screening to at least two therapies
Exclusion Criteria
- Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy - Inadequate organ function during screening and prior to randomization - History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization - Human immunodeficiency virus (HIV) positivity at screening. - Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening. - Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening. Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental rapcabtagene autoleucel |
rapcabtagene autoleucel |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky
Lexington 4297983, Kentucky 6254925 40536-0284
Lexington 4297983, Kentucky 6254925 40536-0284
More Details
- NCT ID
- NCT06581198
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals