The primary objective of this study is to evaluate the safety of lung cancer specific cytotoxic lymphocytes (LC-CTLs). The secondary objectives are to evaluate the rate of successful LC-CTLs generation in vitro and determine the anti-lung cancer efficacy.
Lung cancer is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. The two main types are small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths. Common treatments include surgery, chemotherapy, and radiotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of lung cancer specific cytotoxic T lymphocytes cells in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg via IV, chest or tumor injection each time
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
Safety of LC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Physiological parameter (measuring cytokine response)
Time frame: 3 months
Functional analyses of LC-CTLs in vitro
The specificity of LC-CTLs in vitro will be analysed by intracellular cytokine staining (ICCS) or enzyme-linked immunospot assay (ELISPOT).
Time frame: 2 weeks
Anti-tumor effects
Biochemical markers and image scan will be got before and after treatment. Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: 1 year
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