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