Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
研究概览
简要总结
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are identified through immunostaining of patient's cancer specimens. Another goal of the study is to learn more about the persistence and function of the ex vivo manipulated antigen-specific T cells in the body.
详细描述
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Lung cancer is a malignancy characterized by uncontrolled cell growth in tissues of the lung. There are two main types of lung cancer, small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). In 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths worldwide. Common treatments include surgery, chemotherapy, and radiotherapy, but in relapsed cancer patients, such treatments often have limited successes.
In this study, the participant's peripheral blood mononuclear cells will be collected for antigen-specific T cell preparation, and/or modified using an advanced lentiviral vector system. Then the antigen-specific T cells, called engineered immune effectors (EIEs) or chimeric antigen receptor modified-T cells (CAR T), which can recognize specific molecules that are expressed by the lung cancer cells, are given back to the participant by intravenous infusion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
- •Age: ≥ 18 years and ≤ 80 years.
- •4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
- •Side Effects of Chemotherapy have subsided.
- •Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
- •Karnofsky/Lansky ≥ 50%.
- •Expected survival ≥ 6 weeks.
- •Initial hematopoietic conditions with
- •neutrophils (ANC) ≥ 1×10^6/L;
- •platelet (PLT) ≥ 1×10^8/L.
- •Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- •serum creatinine ≤ 2×ULN;
- •serum bilirubin ≤ 3×ULN;
- •AST/ALT ≤ 5×ULN.
- •10. Oxygen saturation ≥ 90%.
- •Written, informed consent obtained prior to any study-specific procedures.
排除标准
- •Airway obstruction caused by tumor.
- •History of epilepsy or other central nervous system diseases.
- •Patients who require systemic corticosteroid or other immunosuppressive therapy.
- •History of prolonged or serious heart disease during QT.
- •history of serious cyclophosphamide toxicity.
- •Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study.
- •Inadequate liver and renal function with
- •serum creatinine > 2.5 mg/dl;
- •serum (total) bilirubin > 2.0 mg/dl;
- •AST & ALT > 3 x ULN.
- •8. Pregnant or lactating females.
- •Serious active infection during screening.
- •Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
- •11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
研究组 & 干预措施
Lung cancer-specific T cells
Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.
干预措施: Lung cancer-specific T cells (Biological)
结局指标
主要结局
Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
时间窗: 3 months
Physiological parameter (measuring cytokine response)
次要结局
- Anti-tumor effects(1 year)
- Persistence and proliferation of engineered antigen-specific T cells in patients(3 months)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute