NCT03778814招募中1 期
TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial
Second Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients with Dose Limiting Toxicity
研究概览
简要总结
Tumor organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.
详细描述
- Choose appropriate patients with KK-LC-1 expression in advanced lung cancer or other solid tumors and matched MHC-A11 typing, with written consent for this study; For cancer without expression of KK-LC-1, fresh tumor tissue should be obtained for RNA/DNA sequencing to computationally identify neoantigen peptides that can be captured by specifically personizedly synthesized poly-MHCI which can be further used to fish appropriate T cells from the patient.
- Perform biopsy to obtain tissue from tumor/lymph node for organoids, TILs, DC and T cells culture, coculture to screening anti-tumor T cells, establish and select monoclonal T cells for TCR cloning;
- Clone TCR sequence that targets KK-LC-1 or neoantigens; collect PBMCs from the blood of the patients, isolate and activate the T cells and generate the TCR-T cells;
- Test the quality and killing activity of the TCR-T cells in vitro and then transplant back the patients via systemic (vein and/or artery) or local injections, and follow up closely to collect related clinical data as needed;
- Evaluate the clinical results as needed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with advanced lung tumor or other solid tumor where biopsy is obtainable
- •Life expectancy >12 weeks
- •Child-Pugh-Turcotte score <7
- •Adequate heart,lung,liver,kidney function
- •Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay
- •Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent. -
排除标准
- •Had accepted gene therapy before;
- •Tumor size more than 25cm;
- •Severe virus infection such as HBV, HCV, HIV, et al
- •Known HIV positivity
- •History of lung transplantation
- •Active infectious disease related to bacteria, virus,fungi,et al
- •Other severe diseases that the investigators consider not appropriate;
- •Pregnant or lactating women
- •Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
- •Other conditions that the investigators consider not appropriate.
结局指标
主要结局
Number of Patients with Dose Limiting Toxicity
时间窗: three months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the TCR-T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
次要结局
- Percent of Patients with best response as either complete remission or partial remission(three months)
研究者
研究点 (1)
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