NCT06785519
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Recruiting · Early Phase 1 · He Huang · registry updated 2025-01-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Inclusion
- \. Age ≥18 years old;
- \. 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.
- \. SLEDAI-2K ≥8 during screening
- \. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
- \. Expected survival \>12 weeks;
- \. 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);
Exclusion
- \. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- \. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- \. Active infected persons who are not cured:
- \. Active hepatitis B or C virus infection;
- \. 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);
- \. Have used any gene therapy products before;