The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
NCT07592754 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-05-18
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
Conditions
- Neuromyelitis Optica Spectrum Disease (NMOSD)
Interventions
- BIOLOGICAL
-
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.
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-15
- Primary Completion
- 2028-12-31
- Completion
- 2029-03-31
Countries
- China
Study Locations
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