A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of CUD005 Injection in Patients With Cirrhosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- DLT,MTD
研究概览
简要总结
The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis
详细描述
The study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation.
Low-dose group: 5.0×107 cells/time; Medium-dose group: 1.5×108 cells/time; High-dose group: 5.0×108 cells/time. Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose.
According to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of DLT, the number of dose groups ascended before DLT is observed, and the MTD is determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI≤30 kg/m2
- •The results of liver histopathological examination were consistent with the Ishak stage of liver fibrosis ≥3 points；
- •Consent to liver histopathological examination before and after cell therapy (The subject is exempted from liver histopathological examination during the screening period, if he has been performed liver histopathological examination within 2 months before signing the informed consent)；
- •Subjects were able to communicate well with the investigator, cooperate with follow-up work, and understand and comply with the requirements of the study.
排除标准
- •Subjects who were Allergic to cell therapy, steroids, and related drugs used in the study；
- •Have malignant tumors, history of organ transplantation or tissue regeneration therapy, active, known or suspected autoimmune diseases, idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, active pneumonia, heart disease that is not well controlled, hypertension, etc;
- •Subjects with stage III or IV hepatic encephalopathy within 3 months before apheresis or currently diagnosed；
- •Virology shows anti-HCV antibodies, HIV-positive, or syphilis antibodies during the screening period；
- •Subjects were HBV surface antigen positive and HBV-DNA titer was ≥ 20 IU/mL during the screening period；
- •Subjects with clinically symptomatic ascites or pleural effusions requiring puncture drainage. Or who had received thoracic and ascites drainage within 2 weeks prior to treatment, had may only show a small amount of ascites or pleural effusions on imaging, except in those without clinical symptoms；
- •According to the judgment of the investigator, the subjects had other factors that may cause the study to be terminated halfway, such as other serious concomitant diseases (such as severe diabetes, mental illness, drug use, etc.), serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
研究组 & 干预措施
Single arm
cell therapy
干预措施: Cell therapy (Biological)
结局指标
主要结局
DLT,MTD
时间窗: 28 days
Dose-limiting toxicity（DLT）: frequency of occurrence, level of dose of DLT toxicity;Maximum tolerated dose (MTD)
次要结局
- All-cause mortality(1 year)
- fibrosis staging and inflammatory grading(180 days)
- TE（Transient elastography）(1 year)