Antigen-specific T Cells Against Lung Cancer
Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer
研究概览
详细说明
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.
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of T cell immunotherapy targeting single or multiple cancer antigens. The lung cancer antigens include known tumor antigens such as MAGE-A1, MAGE-A4, MucI, GD2, and mesothelin, as well as novel cancer antigens. Another goal of the study is to learn more about the persistence and function of the specific CAR T cells in the body.
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510415
- 招聘中
- Jinshazhou Hospital of Guangzhou University of Chinese Medicine
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接触：
- Qichun Cai, MD
- 电话号码：86-13802830754
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Shenzhen、Guangdong、中国、518000
- 招聘中
- Shenzhen Geno-immune Medical Institute
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Yunnan
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Kunming、Yunnan、中国、650000
- 招聘中
- Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
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接触：
- Xun Lai, MD
- 电话号码：13577096609
- 邮箱：1729112214@qq.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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%. 11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
- 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. 9. Serious active infection during screening. 10. 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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1 infusion, for 1x10^6~1x10^7 cells/kg via IV
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
大体时间：3 months
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Physiological parameter (measuring cytokine response)
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Persistence and proliferation of engineered antigen-specific T cells in patients
大体时间：3 months
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The expansion and functional persistence of ex vivo engineered T cells in the peripheral blood of patients will be examined on Day 7, 14, 21, 28, 60 and 90 after infusion.
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3 months
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抗肿瘤作用
大体时间：1年
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客观反应，如完全反应（CR）、部分反应（PR）、疾病稳定（SD）或疾病进展（PD）将通过实体瘤反应评估标准（RECIST）v1.1标准进行评估。
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1年
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合作者和调查者
调查人员
- 研究主任：Qichun Cai, MD、Jinshazhou Hospital of Guangzhou University of Chinese Medicine
- 研究主任：Xun Lai, MD、Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
肺癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利