Description
Inclusion Criteria:
- * Male or female adults ≥18 years and \<40 years of age at the time of signing the informed consent form (ICF).
- * Diagnosed with SLE by the 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 ≥8 points (with a clinical SLEDAI ≥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.
Exclusion Criteria:
- * 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.
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No