This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with relapsed or refractory Neuromyelitis Optica, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CAR-T cells in the treatment of R/R neuromyelitis optica
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Dose limited toxicity (DLT)
Dose limited toxicity
Time frame: From date of initial treatment to Day 28 post CAR-T infusion.
AE and SAE
Adverse event and serious adverse event
Time frame: From admission to the end of the follow-up, up to 2 years
Maximum tolerable dose
Maximum tolerable dose
Time frame: From date of initial treatment to Day 28 post CAR-T infusion.
Changes in serum AQP4-IgG titer after infusion
Changes in serum AQP4-IgG titer after infusion
Time frame: days 7, 14, 21, 28 and 90
Annual recurrence rate (ARR) of NMOSD
Annual recurrence rate (ARR) of NMOSD
Time frame: From admission to the end of the follow-up, up to 2 years
Changes in the expanded disability status scale (EDSS) score from baseline
EDSS:0 (normal neurological exam) to 10 (death due to MS),Higher scores indicate greater disability (worse outcome),Score reduction suggests functional improvement
Time frame: days 7, 14, 21, 28 ,56 and 90
MRI active lesions
Proportion of subjects with ≥1 active lesions at Day 90
Time frame: days 90
Changes in optimal corrected vision
Changes in optimal corrected vision (Log MAR)
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Time frame: days 28 and 90
Changes of nerve fiber layer around the retinal papilla(pRNFL)
Change in RNFL by optical coherence tomography over trial
Time frame: 2 years
Changes in the plexiform layer of macular ganglion cells (mGCIPL)
Proportion of subjects with significant mGCIPL thickness changes
Time frame: 2 years