NCT05447234尚未招募早期 1 期
Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 50 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- tumor volume
研究概览
简要总结
To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.
详细描述
- Sign the informed consent for clinical trials
- Subject screening
- Extract the blood of the subjects and isolate the PBMC
- Find a patient-specific tumor-specific TCR sequence combination, which is a multi-targeted tumor-specific combination.
- Transfer of personalized tumor-specific TCRs into patient autologous CD8 T cells by gene editing
- Large-scale culture and expansion of gene-edited T cells
- T cell viability, infection efficiency and microbial detection in hospital
- Calculate the number of cells in the patient's body according to TCRx T
- Injecting TCRx T cells back into the subject
- Within 7 days after the injection, the subject's post-dose reaction should be closely observed in the hospital
- After the first injection, continue to reinfuse TCRx T cells up to 4 times according to the treatment effect and the incidence of adverse events, and be hospitalized after each injection to closely monitor possible adverse events
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
- •Age 18-70 years old;
- •Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
- •Expected survival time ≥ 3 months
- •Eastern Cooperative Oncology Group (ECOG) score 0-2
- •According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
- •Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕)
- •Normal liver and kidney function: serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) <2.5UNL, alkaline phosphatase <5UNL; serum creatinine <1.5mg/dl;
- •Men and women must take appropriate contraceptive measures.
排除标准
- •Patients with previous non-gastric/gastroesophageal junction malignant tumor
- •History of severe acute allergy
- •There is an uncontrolled infection
- •History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
- •History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
- •History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure
- •Poor control of hypertension
- •QT interval >480ms
- •Evidence of active bleeding or bleeding tendency
- •Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation
- •Grade 3 or 4 diarrhea
- •Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures
- •Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration
- •Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish
- •Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia
- •Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study
- •Pregnant or lactating women
- •Men or women planning to become pregnant within the next six months
结局指标
主要结局
tumor volume
时间窗: about 2 years
RECIST 1.1
Overall Survival
时间窗: about 2 years
The time from randomization to death due to any reason.
次要结局
- AEs(about 2 years)
研究者
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