A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

Inclusion criteria

• 1. Age ≥18 years old, ≤70 years old;
• 2. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
• 3. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
• 4. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
• 5. SLEDAI-2K score≥7.
• 6. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems
• 7. PGA > 1.0;

Exclusion criteria

• 1. Severe lupus nephritis within 8 weeks before screening;
• 2. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
• 3. uncontrolled lupus crisis within 8 weeks before screening;
• 4. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
• 5. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
• 6. complicated with other autoimmune diseases;
• 7. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
• 8. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
• 9. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;
• 10. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,
• 11. active bacterial, fungal, or viral infection within 2 weeks before apheresis;