Evaluation of the Safety, Tolerability and Efficacy of a Gene Therapy Drug for the Treatment of Pediatric Fabry Disease

Inclusion Criteria:

1. The participant's legal guardian fully understands the objectives, nature, methodsand potential risks of the study and signs a written informed consent; If theparticipant is >= 8 years old, the participant must also agree to participate in thestudy and sign a written informed consent;

2. Decreased α-Gal A (α-galactosidase A) and confirmed diagnosis of Fabry Disease bygenetic testing;

3. Males or females aged ≥7 years and <18 years old;

4. Acceptable eGFR (estimated Glomerular Filtration Rate) result in screening period;

5. Participants had at least one of the clinical manifestations for Fabry disease;

6. Acceptable capsid antibody titers;

7. Acceptable anti α-Gal A antibody titers;

8. Acceptable laboratory values;

9. Participant's legal guardian and participant with good cooperation and compliance;

10. Use of reliable contraception methods during the study for adolescence.

Exclusion Criteria:

1. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV-DNA),positive for hepatitis C virus RNA (HCV-RNA), positive for HIV or syphilis;

2. Have potential liver diseases;

3. Heart failure and severe arrhythmias;

4. Severe allergic reactions for enzyme replacement drugs or other medications;

5. Acute/chronic infections;

6. End-stage renal disease;

7. Have a vaccination history within 30 days prior to screening, or have a vaccinationplan during the screening period and the main study period;

8. Have received gene therapy or used other investigational drugs within four weeksprior to dosing;

9. Other conditions that make the participant not eligible for the study according tothe investigator.