A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus

A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.

Inclusion Criteria:

• Male or female, between 18 and 65 years old;
• Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
• Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
• SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
• Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
• Good organ functions;
• Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

• Had or has active malignancy;
• Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
• Combined with other autoimmune disease that needs treatment;
• Pregnant or lactating women;
• Has other factors that deemed not suitable by investigator.