NCT04348643撤回1 期
Clinical Study of CEA-Targeted CAR-T Therapy in Patients With Relapsed and Refractory CEA+ Cancer
Chongqing Precision Biotech Co., Ltd2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adverse events that related to treatment
研究概览
简要总结
This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
详细描述
CEA is a classic tumor marker, especially in more than 80% of colorectal cancer patients. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of the digestive tract cells, and the CEA is expressed toward the cell cavity under physiological conditions to avoid recognition by CAR-T cells targeting CEA. This is a study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy,and obtain the recommended dose and infusion plan.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No gender limitation, age 18-75 years old (including boundary value);
- •Late, metastatic, or recurrent malignant tumors that have received at least first-line standard treatment failure (progressive or intolerable disease, such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, and the tumor CEA positive expression (tumor CEA positive or serum CEA level> 50ng / ml confirmed by histology or pathology);
- •There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
- •The expected survival time is more than 12 weeks;
- •No serious mental disorders;
- •The functions of important organs are basically normal:
- •Blood routine: white blood cells> 2.0 × 10^9 / L, neutrophils> 0.8 × 10^9 / L, lymphocytes> 0.5 × 10^9 / L, platelets> 50 × 10^9 / L, hemoglobin> 90g / L;
- •Cardiac function: cardiac ultrasound indicates that the cardiac ejection fraction is ≥50%, and there is no obvious abnormality on the electrocardiogram;
- •Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN;
- •Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN;
- •Blood oxygen saturation> 92%.
- •There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation);
- •There are no contraindications for apheresis or intravenous blood collection or other cell collection;
- •The patient or his guardian agrees to participate in this clinical trial and sign the ICF, indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the study.
排除标准
- •Have received CAR-T treatment or other genetically modified cell treatment before screening;
- •Participated in other clinical studies within 1 month before screening;
- •Received the following anti-tumor treatment before screening: received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except for those who have confirmed disease progression after treatment;
- •Have received live attenuated vaccine within 4 weeks before screening;
- •Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
- •Suffering from any of the following heart diseases:
- •New York Heart Association (NYHA) stage III or IV congestive heart failure;
- •Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment;
- •Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for conditions caused by vasovagal or dehydration);
- •Severe cardiac insufficiency, severe heart valve disease and other cardiovascular system diseases;
- •There are active infections or uncontrollable infections requiring systemic treatment within 2 weeks before screening;
- •Active autoimmune diseases;
- •Suffering from chronic enteritis and / or intestinal obstruction;
- •Suffering from other malignant tumors, in addition to fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- •Women who are pregnant or breastfeeding;
- •The situation that other researchers think is not suitable for participating in the study.
研究组 & 干预措施
CEA+ CAR-T
Experimental
CAR-T cell reinfusion is carried out in 1~3 times
干预措施: CEA CAR-T cells (Biological)
结局指标
主要结局
Adverse events that related to treatment
时间窗: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
次要结局
- Quantity of CEA CAR copies in peripheral blood(2 years)
- Levels of CRP in Serum(3 months)
- Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer(2 years)
- The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy(6 months)
- Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer(2 years)
- Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer(2 years)
- Levels of CEA in Serum(2 years)
- Rate of CEA CAR-T cells in peripheral blood(2 years)
- Levels of IL-6 in Serum(3 months)
研究者
研究点 (2)
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