Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder

Inclusion criteria

• Male or female subjects aged 18-60 years;
• Patients must be diagnosed as AQP4-IgG-positive NMOSD;
• At least one immunosuppressant has been used for over a year with poorly controlled symptoms;
• Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.
• Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.
• Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.

Exclusion criteria

• Subjects have received B cell deletion treatment within 6 months before screening;
• Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
• Subjects with Papovaviruses infection.
• Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
• History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
• Pregnant or lactating women.
• Subjects with severe heart, liver, kidney or bone marrow function disorder.
• Allergic constitution or a history of severe allergies.
• Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.