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

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

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 of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
• 3. SLEDAI-2K ≥8 during screening
• 4. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
• 5. Expected survival >12 weeks;
• 6. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (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 as severe 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 systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
• 6. Have used any gene therapy products before;
• 7. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation 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 unsuitable for enrollment;
• 10. HIV-infected people;
• 11. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.