Evaluate the Safety and Preliminary Efficacy of EXG110 in Subjects With Fabry Disease

Exclusion Criteria

• •1. Screening period laboratory test results: a) aspartate aminotransferase or alanine aminotransferase \> 1.5× upper limit of normal (ULN);b) Total bilirubin \> 1.5× upper limit of normal (ULN);c) Alkaline phosphatase \> 2× upper limit of normal (ULN);d) Albumin \< lower limit of normal (LLN)
• •2. There was a clinically significant increase in AFP during the screening period
• •3. Serum virology test: a) Hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) higher than the upper limit of normal detection;b) Hepatitis C: if the hepatitis C virus (HCV) antibody is positive, and the hepatitis C virus-ribonucleic acid (HCV-RNA) is higher than the upper limit of normal test value;c) Syphilis: positive for syphilis screening (Tp-Ab) and positive for syphile-specific antibodies;d) HIV: Known human immunodeficiency virus (HIV) positive history or HIV screening positive
• •4. AVT917 (\>1:50), anti-AGA antibody positive(\>1:2560)
• •5. C3 lower than the normal range, C5b-9 higher than the normal range, anti-AVT917 IgM positive
• •6. Current or have a history of serious cardiovascular disease and surgical history
• •7. Current underlying liver disease or history of liver disease, as assessed by the investigator, that may affect the safety assessment of the drug
• •8. Renal disease in adult and the slope of kidney \>5 mL/min/1.73m²/year
• •9. Subjects with poorly controlled diabetes after drug treatment (e.g., HbA1c≥8%);
• •10. Acute/chronic infection or other chronic disease that the investigator determines will increase the risk of participants participating in the study
• •11. Patients with a history of malignant tumor or currently suffering from any malignant tumor (except for the following tumor diseases: skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma has been controlled after treatment);
• •12. Have malignancy cancer
• •13. Patients with active autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, immune vasculitis, inflammatory bowel disease, etc.);
• •14. known history of allergy to the components of the investigational products
• •15. Patients with a history of drug use or drug abuse or alcoholism
• •16. Use of systemic (intravenous or oral) immunomodulators within the past 6 months or currently
• •17. Initiation of treatment with blood pressure lowering drugs that affect proteinuria levels (such as angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or angiotensin-receptor/enkephalin inhibitors) within 4 weeks prior to screening, or changes in the therapeutic dose of these drugs within 4 weeks prior to screening;
• •18. Has received, or is currently receiving, a clinical trial of another investigational drug/medical device or treatment (other than vitamins and minerals) within 3 months prior to signing the informed consent (or within 5 half-lives of the investigational drug, whichever is longer)
• •19. Previous treatment with gene therapy products
• •20. Those who had received live attenuated vaccine/vaccine within 12 weeks prior to screening or planned to receive it during the study
• •21. Other clinical conditions that the investigators felt needed to be ruled out