This is an open label, Multi-center,dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
1.0-4.0×10\^6 CAR-T cells/kg
DLT
The number and severity of dose-limiting toxicity (DLT) events
Time frame: Within28 Days After BRL-302 Infusion
AEs
The total number, incidence, and severity of AEs
Time frame: Up to 12 Months After BRL-302 Infusion
Annualized relapse rate (ARR)
Number of NMOSD relapses in subjects after cell infusion divided by observation time (years)
Time frame: 1,3,6,12 month after BRL-302 infusion
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