Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.
详细描述
The tumor-specific "none-self" immunogenic neoantigens encoded by either viral genes or somatic mutation genes, possess the potential to induce specific anti-cancer immunity, including cellular and humoral immune responses. Today, numerous clinical trials demonstrate that although these "none-self" antigens initiate the antigen-specific immunoglobulin G antibodies and cluster of differentiation 4（CD4）+/cluster of differentiation 8（CD8）+T-cells response, not all of them show a clinical benefit in the response rate, progression-free survival or overall survival.Personalized cell therapy maybe own a breakthrough in the treatment of those gastric cancer patients without standard options.The investigators' center has successfully established a new method for preparing personalized neoantigen reactive T cells(NRTS) for adoptive cell therapy(ACT). Today, the investigators will carry out a single arm clinical prospective study of NRTs for the treatment of Chinese patients with advanced gastric cancer. Participants are assigned to receive 4 circles of cell therapy, and IL-2 continuous intravenous infusion（CIV） will also be given for 5 consecutive days after each time's cell infusion. The safety and clinical response rate（RR） are evaluated. Biomarkers and immunological markers are also monitored.
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
- •Voluntarily join the study and sign the informed consent;
- •Age: 18-75 years old, male or female;
- •Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the "Gastric Cancer Diagnosis and Treatment Guide" issued by China's "Chinese Clinical Oncology Society".) ;
- •Have at least one measurable lesion according to imRECIST evaluation criteria;
- •Expected survival ≥5 months (starting from the collection of tissue samples for sequencing);
- •The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2;
- •The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L; Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L;
- •The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN.
- •Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks.
排除标准
- •Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis;
- •Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group;
- •Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction;
- •Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs;
- •Central nervous system (CNS) metastatic and/or cancerous meningitis;
- •People who may be allergic to immunotherapy;
- •Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study;
- •Pregnant and lactating women;
- •Participating in other clinical trials;
- •An uncertainty that the investigator believes has an impact on the subject's safety or compliance.
结局指标
主要结局
Number of participants with Adverse Events
时间窗: up to 6 months
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
次要结局
- Progression free survival (PFS)(Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months)
- Response Rate(Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months)
研究者
Shen Xian
Chief Physician
First Affiliated Hospital of Wenzhou Medical University