A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

Exclusion Criteria

• •1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
• •2. Subjects with chronic active immune system diseases undergoing systematic treatment;
• •3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
• •4. Received the prescribed drug treatment at the prescribed time before first dose;
• •5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
• •6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
• •7. Pregnant or lactating women; Subjects with birth plans during the trial;
• •8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
• •9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
• •10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
• •11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;
• •12. Subjects with severe or persistent infection currently or within the 1 months prior to screening;
• •13. Subjects with positive gamma interferon release test;
• •14. Subjects who currently have active hepatitis or have a history of severe liver disease;
• •15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
• •16. Abnormal laboratory test results;
• •17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
• •18. Subjects with symptoms of severe mental illness who are clinically uncooperative;
• •19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.