NCT03085966Unknown1 期
Study of Autologous Immune Cell Therapy in Combination With the Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) in Patients With Metastatic Castration-resistant Prostate Cancer
Shanghai AbelZeta Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AE and SAE
研究概览
简要总结
Study of autologous immune cell therapy in combination with the luteinizing hormone releasing hormone agonists (LHRH-a) in patients with metastatic castration-resistant prostate cancer
详细描述
Autologous dendritic cells (DC) are known to activate other immune cells, such as central memory T cells (Tcm cells), that are able to mount an attack against cancer cells. The purpose of this study is to evaluate the feasibility, safety and efficacy of patients' own immune cells combined with the luteinizing hormone releasing hormone agonists (LHRH-a) for treatment of metastatic castration-resistant prostate cancer.
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
- •Males age ≥ 18 years；
- •Subjects who understand and sign the consent form for this study；
- •Metastatic， castrate resistant, histologically confirmed prostate cancer；
- •PSA> 5ng / ml；
- •Serum testosterone ≤ 17nmol / L (50ng / dl)；
- •Expected survival time of at least 24 months；
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
- •Subjects did not receive chemotherapy, radiation therapy, surgery and other treatment within 4 weeks；
排除标准
- •The subject has an allergic history of medicine or food；
- •The patient with more serious heart disease, including but not limited to myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia；
- •Hb <9.0 g / 100ml, WBC <3 ×10^9/ L, LY <1.0 x10^9/ L, platelet <100,000 / mm3；
- •Patients with immune disease or auto-immune disease (such as Multiple sclerosis, systemic lupus erythematosus，rheumatoid arthritis and inflammatory bowel disease, vitiligo )；
- •The subject has uncontrolled or hard-to-control diseases of liver, or kidney system；
- •Patient with visceral metastases, pathological fractures, spinal cord compression symptoms；
- •Severe pain associated with bone metastases (VAS score ≧ 4 points)；
- •Patient has received immunotherapy (including but not limited to PD-1 / PDL-1, etc.)；
- •patient with irregular hemorrhagic disease；
- •Subject is HIV, hepatitis B virus, hepatitis C virus, Treponema pallidum infection；
- •Subject has uncontrollable seizures, or because of mental loss of self-knowledge and so on；
- •The subject has an history of other malignant tumor；
- •The patient had drug abuse, drug abuse, and long history of alcoholism in the 12 years prior to this trial；
- •The subject has participated in any other clinical trial in the 3 months prior to this trial；
- •The subject has any other unsuitable or adverse condition to be determined by the investigator.
研究组 & 干预措施
autologous immune cell therapy
Experimental
Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)
干预措施: autologous immune cell therapy (Biological)
结局指标
主要结局
AE and SAE
时间窗: 24 months
Incidences of adverse events or serious adverse events
次要结局
- OS(24 months)
- PFS(24 months)
研究者
研究点 (1)
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