The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese PLA General Hospital
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Viral infections: Known HIV, active HBV, or active HCV.
Pregnant or breastfeeding women.
History of other autoimmune diseases requiring immunosuppressive therapy.
Use of any live vaccines against infectious disease within 6 weeks before enrollment.
Trial design
Treatments tested in this trial
- KSVCBD injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov