About this trial
This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Anti-BAFFR CART