Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

Inclusion Criteria:

(2) Expected survival time ≥3 months; (3) Subjects with recurrent/refractory autoimmune disease who have failed standard treatment or lack effective treatment, including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.

(4) 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 abnormalitiesdue to disease, such as liver infiltration or bile duct obstruction, weredetermined to be less than 5×ULN. If Gilbert syndrome is diagnosed, thetotal bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN. (5) no serious mental disorders; (6) Can understand this test and havesigned the informed consent.

Exclusion Criteria:

1. 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;

2. 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;

3. 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;

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

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

6. 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;

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

8. Participated in other clinical studies 1 month before screening;

9. Evidence of central nervous system invasion during subject screening;

10. Mental patients with depression or suicidal thoughts;

11. Those who received live vaccine within 28 days prior to screening;

12. Situations considered unsuitable for inclusion by other researchers.