TN10 Anti-CD3 Prevention

Up to ten percent of all diagnosed diabetics have type 1 diabetes. Type 1 diabetes is a condition that develops due to an autoimmune attack against beta cells in the pancreas, which causes the body to stop producing insulin. Occurring most often in children and young adults, this type of diabetes appears suddenly and can lead to lifelong health complications. Relatives of people with type 1 diabetes have a greater risk of developing the disease. Type 1 Diabetes TrialNet is an international clinical trials network sponsored by NIH which conducts studies to find ways to prevent or delay the development of the disease and to enhance treatment for the newly diagnosed.

Teplizumab (Anti-CD3) is a monoclonal antibody that interferes in the autoimmune attack of pancreatic beta cells. Previous studies have shown that teplizumab reduces the loss of insulin production in type 1 diabetics during the first year after diagnosis. TrialNet 10 is a phase 2 prevention trial of TrialNet, studying the effect of teplizumab on insulin production in the relatives of type 1 diabetics who are at high risk of developing the disease. TrialNet 10 is projected to last 4-6 years with an enrollment period of 2-3 years. The approximate enrollment of the study is 140-170 individuals between the ages of 8-45 years. Subjects will be randomly assigned to either the active or placebo group of the study, and monitored and tested over time until diagnosed with diabetes.

在所有确诊的糖尿病患者中，多达10%患有1型糖尿病(Type 1 diabetes)。1型糖尿病是一种因免疫系统对胰腺β细胞发起自身免疫攻击而引发的疾病，进而导致机体无法合成胰岛素。该病症多发作于儿童与青年群体，起病突然，且可能引发终身性健康并发症。1型糖尿病患者的亲属罹患该病的风险显著更高。1型糖尿病试验网络(Type 1 Diabetes TrialNet)是由美国国立卫生研究院(National Institutes of Health, NIH)资助的国际临床试验网络，旨在开展相关研究以探寻预防或延缓该病发病的方法，并优化新发确诊患者的治疗方案。
替普单抗(Teplizumab，抗CD3)是一种可干扰胰腺β细胞自身免疫攻击过程的单克隆抗体(monoclonal antibody)。既往研究表明，在确诊后的第一年中，替普单抗可减少1型糖尿病患者的胰岛素合成损失。TrialNet 10是该试验网络开展的一项2期预防临床试验，旨在评估替普单抗对罹患该病风险较高的1型糖尿病患者亲属的胰岛素合成水平的影响。该试验预计总时长为4至6年，其中受试者招募周期为2至3年。本研究计划招募约140至170名年龄介于8至45岁之间的受试者。受试者将被随机分配至试验给药组或安慰剂组，并接受长期随访监测与检查，直至确诊糖尿病。