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.
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 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;
Single group
Anti-BAFFR CART
DrugAnti-BAFFR CART
Incidence of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) will be evaluated within the first 28 days following BAFFR CART cells infusion.
Incidence and severity of adverse events
Adverse events will be evaluated following the chemotherapy preparative regimen and infusion of BAFFR CART cells within the first 28 days.
Proportion of BAFFR CART cells in peripheral blood
The proportion of BAFFR CART cells in peripheral blood will be detected after infusion.
Annualized relapse rate (ARR)
ARR is defined as the number of attacks divided by the total participant-years after infusion.
Changes of B cell levels in bone marrow and peripheral blood
The changes of B cell levels in bone marrow and peripheral blood after BAFFR CART infusion.
Changes of AQP4 antibody titers
Changes of AQP4 antibody titers from baseline over 1 year after BAFFR CART infusion.
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This trial is not recruiting at the moment. You can still explore other options:
