Clinical Study of Targeted T-cell Therapy in Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.
详细描述
In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.
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
盲法说明
targeted activated T-cell
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
- •Age: 18~75 years old;
- •Patients with solid tumors still show progress after radiotherapy, chemotherapy and targeted therapy, with at least one measurable lesion;
- •No congenital autoimmune diseases or immunodeficiency diseases;'
- •At least one or more solid tumor targets of HER2, MUC1, CEA, EGFR and GPC3 were positive by immunohistochemical examination of tumor tissues;
- •No serious infectious diseases (hepatitis b, c, syphilis, AIDS);
- •Sign informed consent voluntarily. -
排除标准
- •The researchers determined that the patient could not complete 6 courses of treatment.
- •Patients with t-cell lymphoma.
- •Pregnant or lactating female patients, or those who do not want to use contraception during the trial.
- •Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.
- •Other patients in the treated group who were considered as unfit for cell therapy.
研究组 & 干预措施
Targeted T-cell
This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses.
干预措施: Targeted T-cell armed with bispecific antibody (Decitabine) (Other)
结局指标
主要结局
OS
时间窗: 1 year .
Overrall survival.The time of patient from randomization to death caused by any cause.
次要结局
- PFS(1 year.)