A Clinical Study to Evaluate the Safety, Initial Efficacy and Pharmacokinetics of a Generic CNK-UT009 Cell Injection for the Treatment of Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user
研究概览
简要总结
This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines.
详细描述
The primary objective of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in the treatment of patients with type 1 diabetes and to determine the maximum tolerated dose (MTD).
Secondary objectives include:
- Assessing the preliminary efficacy of CNK-UT009 cell injection in treating patients with type 1 diabetes;
- Evaluating the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection;
- Assessing the impact of CNK-UT009 cell injection reinfusion on peripheral blood immune cells;
- Assessing the impact of CNK-UT009 cell injection reinfusion on serum cytokines;
- Evaluating the immunogenicity of CNK-UT009 cell injection.
The primary endpoints of this clinical trial are:
- Safety and tolerability endpoints: Adverse events occurring after the reinfusion of CNK-UT009 cell injection, including the type, frequency, and severity of treatment-emergent adverse events (TEAEs), to determine the maximum dose-limiting toxicity (DLT) and tolerated dose (MTD);
- Primary efficacy endpoint: Changes in serum C-peptide peak and area under the curve (AUC) after a 2-hour mixed meal tolerance test (MMTT) before and after the reinfusion of CNK-UT009 cell injection.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in pat
This is a single-arm, open, investigator-initiated clinical study of CNK-UT009 cell injection in patients with type 1 diabetes. The purpose of this study is to evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes mellitus, determine the maximum tolerated dose (MTD), and evaluate the initial therapeutic effectiveness, PK characteristics and immunogenicity of CNK-UT009 cell injection. And the effect of CNK-UT009 cell injection on peripheral blood immune cells and serum cytokines.
干预措施: CNK-UT009 cell injection (Biological)
结局指标
主要结局
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user
时间窗: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
Safety and tolerability endpoints: Adverse events that occurred after reinfusion of CNK-UT009 cell injection. The type, occurrence frequency and severity of (TEAE) determine that dose-limiting toxicity (DLT) is the greatest Tolerated dose (MTD)
CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the effectiveness of it
时间窗: The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months
The primary efficacy endpoint: A 2-hour mixed meal tolerance test before and after reinfusion of CNK-UT009 cell injection The changes of the peak value of serum C-peptide and the area under the curve (AUC) after stimulation by (MMTT)
次要结局
- CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of peripheral blood immune cell subsets of the patient(The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months)
- CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of serum cytokines of the patient(The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months)
- To evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection(The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months)
- CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the immunogenicity of the individual(The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months)