FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Study Description
Eligibility
Male or female adults ≥18 years and ≤45 years of age at the time of signing the informed consent form (ICF).
Diagnosed with SLE by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
Positivity for antinuclear antibody, anti-ds-DNA antibody, and/or anti-Smith antibody at screening.
Active SLE at screening, as defined by SLEDAI-2K ≥8 points (with a clinical SLEDAI-2K ≥4 points, excluding alopecia, mucosal ulcers, and fever); AND one or more major organ systems with British Isles Lupus Assessment Group (BILAG) A score, excluding musculoskeletal, mucocutaneous, and/or constitutional organ systems.
Failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.
Body weight <50 kg.
Active neurological symptoms of SLE at screening.
Potentially irreversible organ damage related to SLE, where in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant.
Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment.
Prior treatment with CAR T-cell therapy within the last 6 months, allograft organ transplant, or hematopoietic stem cell transplant.
