Interventional Treatment of Lung Cancer (LC) With LC Specific Immune Lymphocytes (LC-CTLs)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety of LC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
研究概览
简要总结
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.
详细描述
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.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written, informed consent obtained prior to any study-specific procedures.
- •Age older than 18 years.
- •Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy.
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or
- •Expected survival ≥ 12 weeks.
- •Not pregnant, and on appropriate birth control if of childbearing potential.
- •Initial hematopoietic reconstitution with
- •neutrophils (ANC) ≥ 1,000/mm^3;
- •platelet (PLT) ≥ 100,000/mm^
- •Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- •serum creatinine ≤ 2×ULN;
- •serum bilirubin ≤ 2×ULN;
- •AST/ALT ≤ 2×ULN;
- •ALKP ≤ 5×ULN;
- •serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
- •Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.
排除标准
- •Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer.
- •Previous exposure to mouse CEA antibody.
- •Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
- •Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
- •Pregnant or lactating females.
- •Inadequate bone marrow function with
- •absolute neutrophil count < 1,000/mm^3;
- •platelet count < 100,000/mm^3;
- •Hb < 9 g/dL.
- •Inadequate liver and renal function with
- •serum (total) bilirubin > 1.5 x ULN;
- •AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
- •alkaline phosphatase > 2.5 x ULN;
- •serum creatinine >2.0 mg/dl (> 177 μmol/L);
- •urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
- •Serious active infection requiring i.v. antibiotics at during screening.
- •Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
研究组 & 干预措施
LC-CTLs
Autologous lung cancer specific cytotoxic lymphocytes
干预措施: LC-CTLs (Biological)
结局指标
主要结局
Safety of LC-CTLs 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
- Functional analyses of LC-CTLs in vitro(2 weeks)
- Anti-tumor effects(1 year)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute