A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer
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
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
详细描述
With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients. NK and NKT cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture. Our previous studies demonstrated that the expansion of NK and NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NK and NKT cells exhibit antitumor effect in vitro and in vivo against a variety of tumor cells. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 4 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 3 year.
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
- •Age: 18 to 75 years, Male or Female
- •Histological or cytologically diagnosis of non-small cell lung cancer
- •Recurrent or metastatic after surgical treatment
- •The pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by CT scan or MRI)，number of Lymph node metastasis is less than 5
- •Refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
- •No chemotherapy and radiation therapy to be planned recently
- •Patients must have a Karnofsky performance status greater than or equal to 70%
- •Life expectancy greater than 3 months
- •Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
- •Agree that progress of the disease must be radiographically measurable by computerized tomography (CT) scanning technique or magnetic resonance imaging (MRI) (per RECIST1.1 criteria)
- •Agrees to participate in long-term follow-up for up to 3 years, if received NK and NKT infusion
- •Laboratory values within the following ranges prior to receiving treatment of study agent: Peripheral blood cells >3×10^9 /L; Number of lymphocytes >1.0×10^9 /L; Lymphocyte ratio >18%; INR<1.5.
排除标准
- •Patients with no surgical treatment
- •Patients within concurrent chemotherapy or radiation
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
- •History of immunodeficiency disease or autoimmune disease
- •Patients with chronic disease which is undergoing immune reagents or hormone therapy
- •Serious infections requiring antibiotics, bleeding disorders
- •Previous bone marrow or stem cell transplant, or organ allograft
- •Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
- •Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
- •Pregnant or breast-feeding patients
- •Lack of availability of a patient for immunological and clinical follow-up
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 3 years
The incidence of adverse events following infusion of NK and NKT cells
时间窗: 30 days post-infusion
次要结局
- Objective Response Rate (ORR)(up to 24 weeks)
- Tumor Marker(up to 24 weeks)
- Progression-Free Survival (PFS)(Approximately 1 years)
研究者
Wenxiang Wang
Professor
Hunan Province Tumor Hospital