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

Summary

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

Eligibility

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.

Conditions2

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