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.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
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
详细描述
KSVCBD-R103 is an open-label study in subjects with NMOSD. The dose-escalation will be conducted to evaluate the safety and preliminary efficacy of KSVCBD. This study consists of a screening period, a treatment period and a follow-up period. During treatment period, the subjects will receive single-dose of KSVCBD injection. The duration of participation for each subject will be approximately 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •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.
- •History of bone marrow/hematopoietic stem cell or solid organ transplantation.
- •Patients deemed unsuitable for participation by the investigator.
研究者
Shihui Wei
Chief Physician and Professor
Chinese PLA General Hospital