An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Evaluation of safety and tolerability
研究概览
简要总结
The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.
详细描述
The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Stable MS disease within 30 days prior to enrollment
- •EDSS Score between 2 and 8 inclusively
- •Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.
排除标准
- •Women who are pregnant or breast-feeding or who plan to become pregnant during the study
- •Has taken immunomodulating drugs within 60 days prior to screening
- •HIV positive
研究组 & 干预措施
Dose Level 1
6-9 million MRTC
干预措施: Tovaxin Autologous T Cell Vaccine (Biological)
Dose Level 3
60-90 million MRTC
干预措施: Tovaxin Autologous T Cell Vaccine (Biological)
Dose Level 2
30-45 million MRTC
干预措施: Tovaxin Autologous T Cell Vaccine (Biological)
结局指标
主要结局
Evaluation of safety and tolerability
时间窗: Yearly Intervals
次要结局
- To assess changes in the myelin-reactive profile in the blood(Yearly Intervals)
- To assess changes in EDSS Scores(Yearly Intervals)
- To assess changes in the frequency of MS relapses(Yearly Intervals)