NCT04966143Unknown早期 1 期
A Study of CLDN18.2 Chimeric Antigen Receptor T Cells in the Treatment of Advanced Pancreatic Cancer
Shanghai Longyao Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall Response rate（ORR）
研究概览
简要总结
CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer.
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
- •They were 18 to 70 years old, male or female;
- •Definitive diagnosis is recurrent or refractory pancreatic cancer;
- •Claudin 18.2 IHC staining was positive in tumor tissues;
- •Life expectancy > 12 weeks;
- •According to RECIST 1.1, there was at least one measurable tumor target;
- •ECoG scores at screening, 24 hours before puncture and baseline (before treatment) were 0-1;
- •Adequate organ function;
- •Women of childbearing age with negative pregnancy test or male subjects must take effective and reliable contraceptive methods until 30 days after the end of treatment;
- •Have enough understanding ability to voluntarily sign informed consent to participate in clinical research.
排除标准
- •Pregnant or lactating women;
- •HIV, syphilis spirochete or HCV serological positive;
- •Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection (HBsAg positive, HBcAb positive, HBV DNA positive);
- •The subjects were judged as clinically significant thyroid dysfunction by the investigators (serum thyroid hormone determination TT4, TT3, FT3, FT4, serum thyroid stimulating hormone TSH) and were not suitable to participate in this study;
- •The side effects of the patients were not recovered to CTCAE ≤ 1;
- •Subjects who are currently using steroids all over the body within 7 days before the pregnancy is taken out; Inhaled steroids are not excluded in the near future or in the near future;
- •Previous allergies to immunotherapy and related drugs, severe allergies or allergies;
- •T cells (including car-t, tcr-t) that have been modified by chimeric antigen receptor have been reported.
- •The subjects had untreated or symptomatic brain metastasis;
- •The subjects had heart disease which needed treatment or after treatment, hypertension was out of control (blood pressure > 160 mmHg / 100 mmHg);
- •Subjects with or waiting for organ transplantation history;
- •No other serious disease may limit subjects' participation in this trial
- •The researchers assessed that subjects were unable or unwilling to comply with the requirements of the study program.
- •It has abnormal signs of central nervous system diseases or abnormal results of nervous system detection, which has clinical significance;
- •Subjects currently or had other malignant tumors that could not be cured within 3 years, except for in situ cervical or skin basal cell carcinoma.
结局指标
主要结局
Overall Response rate（ORR）
时间窗: 1month
the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
次要结局
- Overal survival （OS）(5 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](1 year)
- Progression free survival（PFS）(1 years)
- Disease Control Rate（DCR）(1 years)
- Duration of Response (DOR）(1 years)
研究者
研究点 (1)
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