Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus
This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.
| Condition(s) | Systemic Lupus Erythematosus |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE. |
| Who can participate | Inclusion Criteria: -Key Inclusion Criteria- * Women or men ≥ 18 years at screening \[Spain only\] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent \[UK only\] * Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus * Positive for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or anti-Smith (\> upper limit of normal \[ULN\]), anti-histone or anti-chromatin (\> ULN) * Severe, refractory SLE Exclusion Criteria: -Key Exclusion Criteria- * Medications * Within 2 months of leukapheresis: use of anti-CD20 therapy * Prior treatment with anti-CD19 therapy (inclu |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Autolus Limited |
| Locations | Barcelona, Spain; Valencia, Spain; Cambridge, United Kingdom; London, United Kingdom; London, United Kingdom; Manchester, United Kingdom |
| Start date | 2024-02-02 |
| NCT ID | NCT06333483 |
| Official listing | https://clinicaltrials.gov/study/NCT06333483 |