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Brief Title: Antigen-specific T Cells Against Lung Cancer
Official Title: Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer
Study ID: NCT03356808
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Jinshazhou Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming, Yunnan, China
Name: Lung-Ji Chang, PhD
Affiliation: Shenzhen Geno-Immune Medical Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Qichun Cai, MD
Affiliation: Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Role: STUDY_DIRECTOR
Name: Xun Lai, MD
Affiliation: Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Role: STUDY_DIRECTOR