A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Recruiting · NCT06581198 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- Key
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.
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 11 US states.
- University Of Alabama - Birmingham, Alabama, United States
- Loma Linda University - San Bernardino, California, United States
- UCSF - San Francisco, California, United States
- UCSF - San Francisco, California, United States
- Sutter Health Network - San Pablo, California, United States
- Ann and Robert H Lurie Childs Hosp - Chicago, Illinois, United States
- Northwestern University - Chicago, Illinois, United States
- University Of Iowa - Iowa City, Iowa, United States
- University of Kentucky - Lexington, Kentucky, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Boston Medical Center - Boston, Massachusetts, United States
- WA Uni School Of Med - St Louis, Missouri, United States
- Duke Clinical Research Institute - Durham, North Carolina, United States
- Oregon Health Sciences University - Portland, Oregon, United States
- Houston Methodist Hospital - Houston, Texas, United States
- Univ Of TX MD Anderson CC - Houston, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- LDS Hospital - Salt Lake City, Utah, United States
- LDS Hospital - Salt Lake City, Utah, United States
- Novartis Investigative Site - Aarhus N, Denmark
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Bordeaux, France
- Novartis Investigative Site - Bucharest, Romania
- Novartis Investigative Site - Budapest, Hungary
- Novartis Investigative Site - Chiba, Japan
- Novartis Investigative Site - Clermont-Ferrand, France
- Novartis Investigative Site - Córdoba, Spain
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Graz, Austria
- Novartis Investigative Site - Groningen, Netherlands
- Novartis Investigative Site - Haifa, Israel
- Novartis Investigative Site - Ishikawa, Japan
- Novartis Investigative Site - Kyoto, Japan
- Novartis Investigative Site - Lausanne, Switzerland
- Novartis Investigative Site - London, United Kingdom
- Novartis Investigative Site - Lübeck, Germany
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Mainz, Germany
- Novartis Investigative Site - Marseille, France
- Novartis Investigative Site - Nantes, France
- Novartis Investigative Site - Nuremberg, Germany
- Novartis Investigative Site - Olomouc, Czechia
- Novartis Investigative Site - Oslo, Norway
- Novartis Investigative Site - Paris, France
- Novartis Investigative Site - Paris, France
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Ramat Gan, Israel
- Novartis Investigative Site - Riyadh, Saudi Arabia
- Novartis Investigative Site - Salamanca, Spain
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Singapore, Singapore
- Novartis Investigative Site - Stockholm, Sweden
- Novartis Investigative Site - Strasbourg, France
- Novartis Investigative Site - São Paulo, Brazil
- Novartis Investigative Site - Taichung, Taiwan
Showing 60 of 101 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →