Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

Inclusion Criteria:

• Expected survival time ≥3 months;

• Subjects with recurrent/refractory autoimmune diseases who have failed standardtreatment or lack effective treatment, Including but not limited to systemic lupuserythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associateddiseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissuedisease-associated interstitial lung disease, immune thrombocytopenia, primarybiliary cholangitis, etc.

• Histological evidence of non-suppurative destructive cholangitis and small bile ductdestruction.

• Liver and kidney function, cardiopulmonary function meet the following requirements:

• Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormalbands;

• Blood oxygen saturation >91% in non-oxygen state;

• Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due todisease, such as liver infiltration or bile duct obstruction, were determined to beless than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can berelaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.

• No serious mental disorders;

• Can understand this test and have signed the informed consent.

Exclusion Criteria:

• Malignant tumors other than R/R AID disease in the 5 years prior to screening,except for adequately treated cervical carcinoma in situ, basal cell or squamouscell skin cancer, local prostate cancer after radical surgery, and breast ductalcarcinoma in situ after radical surgery;

• Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb)positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is notwithin the normal reference value range; Hepatitis C virus (HCV) Antibody positiveand peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiencyvirus (HIV) Antibody positive; Syphilis positive;

• Serious heart disease, including but not limited to unstable angina, myocardialinfarction or bypass or stent surgery (within 6 months prior to screening),congestive heart failure (NYHA classification ≥III), and severe arrhythmia;

• Systemic diseases that are deemed unstable by researchers: including but not limitedto severe liver, kidney, or metabolic diseases that require drug treatment;

• Active or uncontrollable infections (except mild genitourinary and upper respiratorytract infections) that require systemic treatment within 7 days prior toadministration;

• Pregnant or lactating women, and female subjects who plan pregnancy within 2 yearsafter cell transfusion or male subjects whose partners plan pregnancy within 2 yearsafter cell transfusion;

• Patients who received CAR-T therapy or other gene-modified cell therapy beforescreening;

• Participated in other clinical studies 1 month before screening;

• Evidence of central nervous system invasion during subject screening;

• Mental patients with depression or suicidal thoughts;

• Situations considered unsuitable for inclusion by other researchers.