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The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
Sponsor: Chinese PLA General Hospital
Summary
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of KSVCBD injection in AQP4-positive Neuromyelitis Optica Spectrum Disorder
Official title: An Early Exploratory Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Relapsed/Refractory AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-05-15
Completion Date
2029-03-31
Last Updated
2026-05-18
Healthy Volunteers
No
Interventions
KSVCBD injection
KSVCBD injection is a CD19/BCMA-targeted in vivo-edited CAR-T cell injection. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses.
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China