An Exploratory Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetics of the Universal CNK-UT009 Cell Injection in Subjects With Difficult-to-treat Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- maximum tolerant dose(MTD)
研究概览
简要总结
Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.
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
- •diagnosed moderate-to- severe IBD patients
- •defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)
- •with complete bone-marrow and organic function
- •no pregnant or planning to become pregnant
- •welling to paticipate
排除标准
- •patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)
- •patients paticipated other clinical trials with four weeks
- •patients with drug combination other than low-dose glucocotiod
- •patients recieved abdominal surgery or live vaccine
- •patients with planned surgery in three months
- •unsuitable situations determined by researchers
研究组 & 干预措施
CNK-UT009 injection
干预措施: injection of CNK-UT009 (Drug)
结局指标
主要结局
maximum tolerant dose(MTD)
时间窗: 12 weeks after first injection
indicate the safty
rate of DLT(dose-limiting toxicity)
时间窗: 12 weeks after first injection
indicate the safety
次要结局
- adverse effects of CNK-UT009(12 weeks)
- pharmacokinetics of CNK-UT009(12 weeks)
- preliminary efficacy of CNK-UT009(12 weeks)