NCT05837299招募中1 期
A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
详细描述
This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
- •Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
- •The expected survival period of the subject is ≥12 weeks.
- •The subject needs to have at least one target lesion that can be stably evaluated.
- •The ECOG score is 0-
- •Subject has adequate organ and bone marrow function
- •All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-
- •Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
- •Subjects must sign and date written informed consent.
排除标准
- •Pregnant and lactating women.
- •Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
- •Serious infection that is active or poorly controlled clinically.
- •Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
- •Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
- •Oxygen saturation ≤ 95% without oxygen inhalation.
- •Suffering from other research diseases that may limit their participation in this study.
- •Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
- •There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
- •Presence of any cardiac clinical symptoms or disorders.
- •Evidence of significant coagulopathy or other significant bleeding risk.
- •Received systemic steroids equivalent to >15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.
- •Prior or concurrent occurrence of other malignancies, with the following exceptions.
- •Subjects who have previously received other gene therapy.
- •Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC
- •Subjects with severe mental disorders.
- •The investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .
研究组 & 干预措施
IMC008 dose 1-3
Experimental
a certain number of IMC008 cell per kg will be infused
干预措施: IMC008 (Drug)
结局指标
主要结局
DLT
时间窗: within 28 days
To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion
次要结局
- OS(upto 96 weeks)
- PFS(upto 96 weeks)
- TRAE(up to 96 weeks)
- Objective response rate (ORR)(upto 96 weeks)
- Tmax(upto 96 weeks)
- Lymphocyte subsets(upto 96 weeks)
研究者
研究点 (1)
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