CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus

Exclusion Criteria

• •1. Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days;
• •2. Any attempted suicide or suicidal ideation within the past year prior to screening;
• •3. Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
• •4. Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
• •5. History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
• •6. History of lymphoproliferative diseases;
• •7. Subjects with malignancy within 5 years prior to screening;
• •8. Have received plasma exchange, plasma separation, hemodialysis, or intravenous immunoglobulin (IVIG) within 14 days prior to screening;
• •9. Other autoimmune diseases requiring systemic therapy;
• •10. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the lower limit of research institution's test range. Subjects with positive hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or syphilis;
• •11. Active or latent tuberculosis at screening;
• •12. Abnormalities in major organ function at screening;
• •13. Previous or current diagnosis of acute or chronic illnesses unrelated to SLE with obviously unstable or uncontrollable clinical symptoms;
• •14. Severe lupus lung damage at screening;
• •15. Severe lupus cardiac damage at screening;
• •16. Presence of uncontrollable infections at screening, requiring antibiotic therapy;
• •17. Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
• •18. Have received intra-articular, intramuscular or intravenous glucocorticoids within 4 weeks prior to screening;
• •19. Have received any commercially available Janus kinase (JAK) inhibitor or Bruton tyrosine kinase (BTK) inhibitor within 12 weeks prior to screening;
• •20. Have received B-cell targeted therapy prior to screening;
• •21. Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
• •22. Previously received therapies with CAR-T cells or other genetically modified T cells;
• •23. Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
• •24. Subjects that have donated blood for ≥ 400mL or had a significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received blood transfusion within 8 weeks, or plan to donate blood during the study period;
• •25. History of ≥grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
• •26. Subjects that have undergone any major surgeries within 12 weeks prior to screening, or those who are scheduled to undergo major surgery during the study period;
• •27. History of drug abuse within 12 weeks prior to screening;
• •28. Female subjects who are pregnant or lactating, or intend to conceive within 2 years after the cell infusion; male patients whose female partners intend to conceive within 2 years after the cell infusion;
• •29. History of any significant drug allergy or intolerance;
• •30. Subjects that have participated in other clinical trials within 3 months prior to screening and/or currently participated in other clinical trials (those who do not receive study drugs are excluded);