KSVCBD injection, a CAR-T cell therapy, for relapsed or hard-to-treat neuromyelitis optica spectrum disorder
Tests KSVCBD injection in adults with relapsed or treatment-resistant AQP4-positive neuromyelitis optica spectrum disorder.
Plain-language title generated from the registry record
Registry title: The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07592754, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT07592754
- Record updated
- 18 May 2026
- Original description
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 DisorderRead full original descriptionShow less
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.
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
Inclusion: Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies; Documented evidence of at least 1 relapse within 12 months before signing the informed consent form; The Expanded Disability Status Scale (EDSS) score ≤ 8; Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period; Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.
Exclusion: Use of any live vaccines against infectious disease within 6 weeks before enrollment; Viral infections: Known HIV, active HBV, or active HCV; History of other autoimmune diseases requiring immunosuppressive therapy; History of bone marrow/hematopoietic stem cell or solid organ transplantation; Pregnant or breastfeeding women; Patients deemed unsuitable for participation by the investigator.