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

Inclusion Criteria:

1. Confirmed NMOSD patients;

2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrencewithin 2 years prior to screening;

3. The blood pregnancy tests were negative within 7 days before the first dose infertile female subjects. The fertile subjects and the male subjects whose partnerare fertile woman agree to use reliable contraception during the study period andwithin 6 months after the study drug discontinuation;

4. Volunteer to participate in clinical research; Fully understand and know the studyand sign the informed consent; Willing to follow and able to complete all testprocedures.

Exclusion Criteria:

1. Subjects with severe NMOSD were judged by the researcher to be unfit to participatein 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 firstdose;

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 tothe first dose;

6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before firstdose;

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 werescheduled to undergo major surgery during the trial;

9. Subjects with severe, progressive, or uncontrolled disease who have been assessed bythe investigator to be at increased risk of participating in the study;

10. A history of gastrointestinal perforation and/or fistula within 6 months prior toscreening;

11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initialadministration, or who plan to receive vaccination during the study period;

12. Subjects with severe or persistent infection currently or within the 1 months priorto screening;

13. Subjects with positive gamma interferon release test;

14. Subjects who currently have active hepatitis or have a history of severe liverdisease;

15. Uncontrolled systemic disease, or any other reason the investigator deemsinappropriate 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 andwho had other conditions that the investigator considered inappropriate to enroll.