Development of Prostate Cancer Dendritic Cell Vaccines
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Events of adverse effects after the DC vaccine injection
研究概览
简要总结
Tumor antigens are protein fragments produced by cancer cells carrying genetic mutations, and many tumor antigens are similar to normal protein antigens, making them unrecognizable by the immune system. Many tumor vaccines are prepared based on a single tumor antigen. This study is based on multiple target antigens using tumor lysates or synthetic peptides. The immune modulation by dendritic-cell (DC)-based cancer vaccines consists of genetically modified DCs to activate T cells to target cancer cells. The study is based on an advanced cancer vaccine technology, which aims to evaluate the safety and potential benefit of the novel immunomodulatory prostate cancer DC vaccines.
详细描述
Prostate cancer is a malignancy originating from the epithelial cells of the prostate gland, ranking as the second most common cancer among men worldwide. Its etiology involves factors such as genetics, age, lifestyle (e.g., high-fat diet, obesity), and hormone levels. High-risk populations are typically men aged 45 and above.
Prostate cancer vaccines based on multiple target antigens derived from tumor lysates or synthetic peptides can serve as antigenic targets for immune cells. The vaccines involve immunomodulation with autologous DCs to stimulate and activate T cells in the body to target cancer cells. The principle of the DC vaccines is simple: to harness and enhance the body's anti-cancer immunity. The process involves simulating antigen-presenting cells with target tumor antigens in culture and then injecting patients with the modified antigen-presenting DCs. Early studies of DC-based vaccines targeting prostate cancer have shown high safety and low toxicity. Here, the study aims to evaluate the safety and efficacy of prostate cancer DC vaccines that use multiple target antigens based on prostate cancer cells to stimulate and induce a specific and strong anti-cancer immune response.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •ECOG performance status 0-1
- •Life expectancy ≥ 12 weeks
- •WBC ≥ 3,500/µL
- •Platelet count ≥ 100,000/µL
- •Hemoglobin ≥ 10.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Fertile patients must use effective contraception
- •Willing to provide blood samples for research purposes
- •Able to complete questionnaire(s) alone or with assistance
- •Able to undergo leukapheresis
- •No known immunodeficiency
- •No other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only
- •No concurrent serious illness
- •No known history of positive PPD skin test
- •Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.
排除标准
- •The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection
- •Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs
- •Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products
- •Active infection with fever
- •Patients with neutropenia (> 10 days) that are difficult to correct after treatment
- •Infection with bacteria, fungi or viruses, uncontrolled
- •Patients with HIV and those living with active HBV and HCV
- •Severe organ failure (heart, liver, kidney, lung)
- •Patients who had previously been treated with cell therapy products and examined by team experts deemed not suitable for treatment
- •Anything that researchers believe may increase the risk of subjects or interfere with test results
研究组 & 干预措施
Experimental: Immunomodulatory DC vaccines to target prostate cancer
Prostate tumor antigen-modified autologous DCs
干预措施: Immunomodulatory DC vaccines to target prostate cancer (Biological)
结局指标
主要结局
Events of adverse effects after the DC vaccine injection
时间窗: up to one month
To assess the safety of autologous prostate cancer DC vaccine in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
次要结局
- Rate of successful prostate cancer DC vaccine generation(up to one month)
- Ability of prostate cancer DC vaccines to induce anti-cancer reaction(after 1 month from prostate cancer DC injection to 12 months after injection)
- Ability of prostate cancer DC vaccines to induce an anti-cancer reaction(after 1 month from prostate cancer DC injection to 24 months after injection)