CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
ConditionLupus Nephritis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHe Huang
About this trial
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
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);
Trial design
Treatments tested in this trial
- CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov