CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

Inclusion Criteria:

1. Age ≥18 years old;

2. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation ofRheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, orV lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPSstandard.

3. SLEDAI-2K ≥8 during screening

4. failure to respond to two or more standard immunosuppressive therapies, orrelapse (increased disease activity index and need to adjust drug dose ortype);

5. Expected survival >12 weeks;

6. Fertile women and men agree to use appropriate contraceptive methods beforeentering the study, during study participation, and for 6 months aftertransfusion (the safety of this therapy for the unborn child is not known);

7. Volunteer to participate in this experiment and sign the informed consent.

Exclusion Criteria:

1. History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such assevere arrhythmia in the past;

3. Active infected persons who are not cured:

4. Active hepatitis B or C virus infection;

5. Patients who have taken more than 20mg/d of prednisone or equivalent systemicsteroid drugs within 1 week prior to treatment (except those who have recentlyor currently taken inhaled steroids);

6. Have used any gene therapy products before;

7. Insufficient amplification ability (<5 times) in response to CD3 / CD28costimulation signals;

8. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;

9. Those who have other uncontrolled diseases that the researcher deems unsuitablefor enrollment;

10. HIV-infected people;

11. Any situation that the investigator believes may increase the risk to thesubject or interfere with the test results.