The Safety and Efficacy of S103 in the Treatment of Refractory Generalized Myasthenia Gravis

Exclusion Criteria

• •1. Any medical or psychiatric condition that the investigator deems may endanger the study participant or affect their ability to participate in the study; or any condition the investigator considers associated with poor compliance;
• •2. Females who are breastfeeding or pregnant, or plan to become pregnant at any time during the 12-month period after receiving CAR-T therapy, or have a history of spontaneous or induced abortion within 4 weeks prior to screening;
• •3. Study participants with clinically relevant active infections (e.g., sepsis, pneumonia, or abscess) or severe infections (requiring hospitalization or antibiotic treatment) within 4 weeks prior to screening;
• •4. Thymectomy within 6 months prior to baseline or planned thymectomy during the study period, or thymoma requiring chemotherapy and/or radiotherapy at any time;
• •5. Study participants who received live attenuated vaccines within 8 weeks prior to screening; or plan to receive live vaccines within 8 weeks after treatment;
• •6. Study participants who received prior rituximab treatment within 6 months before screening;
• •7. Treatment with tocilizumab, eculizumab, or efgartigimod within 3 months prior to screening;
• •8. Intravenous immunoglobulin, plasma exchange, or immunotherapy within 4 weeks prior to screening;
• •9. Known severe underlying diseases, such as liver or kidney dysfunction, hematologic disorders, prior severe cardiovascular diseases, severe hypertension, diabetes, or poorly controlled blood pressure or blood glucose;
• •10. Unresected thymoma;
• •11. Rapid symptom deterioration during the lead-in period, progressing to crisis or pre-crisis state (MGFA IVb-V);
• •12. Other conditions deemed by the investigator as unsuitable for study participation.