A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 66
- 主要终点
- To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
研究概览
简要总结
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).
详细描述
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 55 years old
- •Presence of myelin reactive T cells at screening
- •Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
- •Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
- •Baseline EDSS score between 0 and 5.5 inclusively
排除标准
- •Unable to produce T cell vaccine
- •Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
- •Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
- •Planned pregnancy, currently pregnant, or breastfeeding
- •Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
结局指标
主要结局
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
时间窗: 1 year
次要结局
- To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading(1 year)