Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

Exclusion Criteria12

• Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy;
• Use of any approved immunosuppressive drugs not listed here within 12 weeks or 5 half-lives (whichever is longer) before screening, unless approved by the medical monitor;
• Participation in any investigational trial involving non-biological agents within 4 weeks or 5 half-lives (whichever is longer) of the investigational product (IP) before screening;
• Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening;
• Administration of live vaccines within 4 weeks before screening;
• History of progressive multifocal leukoencephalopathy;
• History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency;
• Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to:
• Poorly controlled diabetes
• Chronic kidney disease stages IIIb, IV, or V
• Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure
• Any severe medical condition or clinically significant laboratory abnormality that, in the judgment of the investigator or medical monitor, would compromise the patient's safe participation and completion of the study or may affect protocol compliance or interpretation of study results.