Active, refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN)
Conditions
Interventions
Experimental: rapcabtagene autoleucel
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women with SLE, aged >= 18 years and == 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 treatment regimens
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving Definition Of Remission In Systemic Lupus Erythematosus (DORIS) or clinical response at Week 24/52. | — |
Countries
Australia, Austria, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, UK, United States
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed