This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.
Age 18-65 years old, male or female;
Routine blood count: hemoglobin ≥60g/L, white blood cell count ≥ 2.5×109/L, neutrophil count ≥1.0×109/L (no colony-stimulating factor treatment within 2 weeks before examination);
Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;
Coagulation function: international normalized ratio (INR) < 1.5×ULN, prothrombin time (PT) <1.5×ULN;
Combined with other connective tissue diseases;
Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and arrhythmias), kidney (eGFR < 15 ml/min/1.73m2), liver (ALT>3×ULN, AST>3×ULN, TBIL >1.5×ULN), lung (FVC<50% predicted or hemoglobin-corrected DLCO<40% predicted), hematologic (leukocyte < 2.5×109/L, neutrophil count <1.0×109/L, HGB<60g/L), etc.;
Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive hepatitis C antibody;
Have active tuberculosis or latent tuberculosis;
Single group
Anti-CD19 IL-10/IL15 CAR-NK
DrugPatients will receive Fludarabine and Cyclophosphamide for conditioning. Multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells will be infused on Day 0, 3, and 6.
The proportion of subjects with DLT
DLT definition is dose-limiting toxicity.
The proportion of subjects with adverse events
Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0.
Changes in SLEDAI-2K scores and the proportions of patients achieving SRI-4 response, DORIS remission, and LLDAS in systemic lupus erythematosus.
changes of mRSS score for systemic sclerosis
definition of improvement by IMACS for IIM
STAR score for sjogren's syndrome
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