CD19/BCMA CAR-T cell therapy for lupus nephritis that returned or resisted treatment
Tests CD19/BCMA CAR-T cells in adults with hard-to-treat lupus nephritis.
Plain-language title generated from the registry record
Registry title: CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- He Huang
- Trial code
- NCT06785519
- Record updated
- 21 January 2025
- Original description
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.Read full original descriptionShow less
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.
Inclusion: 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: 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; 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 3. Active infected persons who are not cured:; 4. Active hepatitis B or C virus infection; 9. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment; 10. HIV-infected people; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 8. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl; 7. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals; 11. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.