The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT05828212
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Hangzhou, Zhejiang, 310000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
CAR-T cells in the treatment of R/R neuromyelitis optica
Time frame: From date of initial treatment to Day 28 post CAR-T infusion.
Dose limited toxicity
Time frame: From admission to the end of the follow-up, up to 2 years
Adverse event and serious adverse event
Time frame: From date of initial treatment to Day 28 post CAR-T infusion.
Maximum tolerable dose
Time frame: days 7, 14, 21, 28 and 90
Changes in serum AQP4-IgG titer after infusion
Time frame: From admission to the end of the follow-up, up to 2 years
Annual recurrence rate (ARR) of NMOSD
Time frame: days 7, 14, 21, 28 ,56 and 90
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 90
Proportion of subjects with ≥1 active lesions at Day 90
Time frame: days 28 and 90
Changes in optimal corrected vision (Log MAR)
Time frame: 2 years
Change in RNFL by optical coherence tomography over trial
Time frame: 2 years
Proportion of subjects with significant mGCIPL thickness changes
Zhejiang University
Other
A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Recurrent/Refractory Neuromyelitis Optica
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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