Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

Inclusion Criteria:

1. At least 18 years old at the time of signing the Informed Consent Form (ICF);

2. Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigatoras unlikely to require respiratory support during the study;

3. At screening, the Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5,with non-ocular items accounting for ≥ 50% of the total score, and GMG ≥ 11;

4. Inadequate response to conventional therapies or lack of effective treatmentoptions, defined as disease recurrence or progression despite treatment withcorticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil,tacrolimus, cyclosporine A, methotrexate), or biologics (e.g., rituximab), and/orlack of effective treatment methods.

Exclusion Criteria:

1. Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy;

2. Use of any approved immunosuppressive drugs not listed here within 12 weeks or 5half-lives (whichever is longer) before screening, unless approved by the medicalmonitor;

3. Participation in any investigational trial involving non-biological agents within 4weeks or 5 half-lives (whichever is longer) of the investigational product (IP)before screening;

4. Participation in any investigational trial involving biological agents within 12weeks or 5 half-lives (whichever is longer) of the IP before screening;

5. Administration of live vaccines within 4 weeks before screening;

6. History of progressive multifocal leukoencephalopathy;

7. History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditarycomplement deficiency;

8. Presence of one or more significant concurrent diseases, as judged by theinvestigator, including but not limited to:

9. Poorly controlled diabetes

10. Chronic kidney disease stages IIIb, IV, or V

11. Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) orrespiratory failure

12. Any severe medical condition or clinically significant laboratory abnormality that,in the judgment of the investigator or medical monitor, would compromise thepatient's safe participation and completion of the study or may affect protocolcompliance or interpretation of study results.