NCT07146672招募中1 期
Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
The study is a controlled, open-label exploratory clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, weight ≥ 40kg; No gender limit；
- •Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger；
- •At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)；
- •Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1;
- •ECOG score 0-1 points;
- •There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery;
- •Organs and bone marrow function well:
- •a:Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
- •b:Platelets ≥ 90 × 10 ^ 9/L;
- •c:Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
- •d:Total bilirubin ≤ 2 times the upper limit of normal value;
- •e:Serum creatinine ≤ 1.5 times the upper limit of normal value;
- •f:Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
- •g:International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
- •Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements
排除标准
- •Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies/ml; or hepatitis C virus RNA copy number above the detection limit.
- •Any uncontrollable active infection, coagulation disorder, or any other major disease;
- •Pregnant or lactating women;
- •Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution;
- •Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement;
- •Major cardiovascular diseases with clinical significance include:
研究组 & 干预措施
Group 1
Experimental
A single dose of 1×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period.
干预措施: Super DC Vaccine (Biological)
Group 2
Experimental
A single dose of 2×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period.
干预措施: Super DC Vaccine (Biological)
结局指标
主要结局
Dose-limiting toxicity
时间窗: Within 28 days after the first injection
Safety
次要结局
未报告次要终点
研究者
研究点 (1)
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