NCT03891706招募中1 期
An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.
Guangzhou FineImmune Biotechnology Co., LTD.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月8日最近更新:
适应症
干预措施
相关药物
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 participants with treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .
The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .
详细描述
This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.
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
- •Aged between 18 and 70 years old, regardless of gender;
- •Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
- •Be after standard treatment or who lack effective treatment programs;
- •Patients and their families were willing to participate in the clinical trial and signed the informed consent;
- •Physical status: ECOG score 0-1;
- •Expected survival time > 3 months;
- •HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte >0.8×10^9/L, hemoglobin >100g/L, and the pregnancy test of female patients with fertility potential was negative.
- •Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST < 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin < 3mg/dl except for Gilberts Syndrome;
- •At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.
- •During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;
- •The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;
- •Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;
- •T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;
- •The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.
排除标准
- •Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
- •Experiencing moderate to severe infection or possible opportunistic infection;
- •Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
- •Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
- •Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
- •Be allergic to any drug used in this study;
- •Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;
- •Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.
研究组 & 干预措施
TCR-T cell infusion
Experimental
Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy
干预措施: tumor-specific TCR-T cells (Drug)
TCR-T cell infusion
Experimental
Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
时间窗: At least 45 days
Keep records the adverse events experienced by subjects in 30 days after the last infusion.
次要结局
- Disease Control Rate(DCR)(one year)
- overall survival(OS)(two year)
- progression-free survival(PFS)(two year)
研究者
研究点 (1)
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