Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.
The enrolled subjects or their legal representatives signed informed consent form;
age range: 18-70 years (including 18 and 70 years), male or female;
Subjects with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria, accompanied by lupus nephritis (SLE-LN) or immune thrombocytopenia (SLE-ITP) and receiving standard treatment;
Subjects with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or simple grade V alone according to 2003 ISN/RPS criteria. Active renal disease was defined as a urine protein: creatinine ratio > 1.0 or proteinuria > 3.5 grams/day.
Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring therapeutic intervention within 60 days after baseline;
Dialysis patients;
Pregnancy or lactation;
Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);
Single group
single dose of CNCT19
Biological/VaccineAutologous 2nd generation CD19-directed CAR-T cells, infusion intravenously.
Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE）
Evaluate the type, frequency, severity of adverse events, and abnormal laboratory test values; Evaluate the frequency and severity of adverse events related to CNCT19.
Overall survival (OS)
The time from the CNCT19 Cell Injection infusion to death due to any cause
SELENA-SLEDAI
0 to 4 is basically no disease activity;5 to 9 is light activity;10 to 14 is moderate activity;≥15 is considered heavy activity.
The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period
To evaluate disease related biomarkers
Levels of anti nuclear antibodies, anti double stranded DNA antibodies, anti small ribosomal nucleoprotein antibodies
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