A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus

Inclusion Criteria:

1. Participants or their guardians understand and voluntarily sign the informed consentform, and be able to complete all the documents, procedures, follow-up examinationsand treatments specified in the study protocol, with good compliance;

2. Age range from 18 to 70 years old, regardless of gender;

3. Body weight ≥ 40kg;

4. Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informedconsent form;

5. active SLE needs to meet the following criteria at screening: SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;

6. Have received at least 8 weeks of standardized treatment for SLE prior to screening;

7. Female participants need to have a negative pregnancy test, and participants agreeto take effective contraceptive measures throughout the study.

Exclusion Criteria:

1. Known hypersensitivity to prednisone, immunosuppressive agents;

2. 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 ≥14days;

3. Suicidal ideation within the past 6 months based on assessment by Columbia-SuicideSeverity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within thepast 12 months or recurrent suicidal behaviors during the subject's lifetime;

4. Presence of SLE or non-SLE related central nervous system diseases or pathologicalchanges within 8 weeks prior to screening;

5. Existence of other lupus crisis within 8 weeks prior to screening;

6. Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skindiseases;

7. Previous or current diagnosis of severe vasculitis due to other diseases excludingSLE;

8. History of vital organ transplantation or hematopoietic stem cell/or bone marrowtransplantation;

9. Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14days prior to screening;

10. Other autoimmune diseases requiring systemic therapy;

11. Active or latent tuberculosis at screening (can be enrolled if appropriatelytreated);

12. Any of severe laboratory abnormalities in liver function, renal function, bonemarrow function, coagulation function, pulmonary function, cardiac function atscreening;

13. History of severe allergy or known hypersensitivity to any of the active ingredientsof the drugs, excipients, or rodent-derived products, xenoproteins included in thistrial, or subjects with allergic constitution;

14. Severe heart diseases;

15. Severe hepatobiliary disease;

16. Presence of medical conditions that are obviously unstable or not effectivelytreated;

17. Presence of uncontrollable bacterial, fungal, viral or other infections, requiringantibiotic therapy;

18. Have received live/attenuated vaccination within 4 weeks prior to screening or planto receive live/attenuated vaccination throughout the study;

19. Have received any commercially available Janus kinase inhibitor or Bruton tyrosinekinase inhibitor within 3 half-lives 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 5half-lives prior to screening;

22. Previous received therapies with CAR-T cells or other genetically modified T cells;

23. Have received therapeutic dose of corticosteroids within 7 days prior toleukapheresis or within 72 hours prior to infusion;

24. Subjects that have undergone major surgery within 4 weeks prior to lymph depletionor those who are scheduled to undergo major surgery during the study period, orwhose surgical wounds have not fully healed prior to enrollment;

25. Subjects that have donated blood for ≥ 400mL or had significant blood lossequivalent to at least 400mL within 4 weeks prior to screening, or have received ablood transfusion within 8 weeks, or plan to donate blood during the study period;

26. History of ≥ grade 2 bleeding within 4 weeks prior to screening or need forlong-term continuous anticoagulant therapy;

27. Subjects with severe mental illness;

28. Alcoholics or subjects with a history of drug abuse;

29. Female subjects who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intendto conceive within 2 years after the cell infusion;

30. History of malignancy；

31. Patients that have contraindications to any of the study procedures or have othermedical conditions that may expose them to unacceptable risk, in the judgment of theinvestigators and/or clinical criteria.