NCT06503497招募中早期 1 期
A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study to Evaluate the Safety and Anti-tumor Efficacy of Second-line Systemic Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~75 years old (including boundary value), both male and female.
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with at least first-line systemic therapy failure.
- •Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-
- •Life expectancy of at least 3 months at screening, as judged by the investigator.
- •At least one stably evaluable target lesion according to RECIST1.1 criteria.
- •Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, with no ongoing supportive care ("yellowing" therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct).
- •Remission of all toxicities due to prior antineoplastic therapy to Grade 0~1 (according to NCI CTCAE version 5.0) or to acceptable levels for inclusion/exclusion criteria.
- •Childbearing status: not pregnant, and if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form to 6 months after the last cell infusion (females of childbearing potential include premenopausal females and females within 2 years of postmenopause).
- •Subjects must sign and date written informed consent.
- •Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up, and other study requirements.
排除标准
- •Pregnant and lactating females.
- •Positive serology for HIV, Treponema pallidum or HCV (those who are HCV antibody positive but HCV-RNA negative, stable syphilis and inactive patients can be included).
- •Any active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of laboratory testing), Epstein-Barr virus (EBV) DNA positive, cytomegalovirus (CMV) DNA positive or novel coronavirus (new coronavirus) nucleic acid positive, and other bacterial, viral, or fungal infections requiring drug treatment;
- •History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- •Any other health condition that, in the judgment of the investigator, would preclude participation in the study.
研究组 & 干预措施
Chemotherapy Sequential NKG2D CAR-NK Cell
Experimental
干预措施: chemotherapy sequential CAR-NK cell infusion (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: within 28 days after NKG2D CAR-NK treatment
Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose
Dose limiting toxicity
时间窗: From enrollment of the first subject to completion of follow-up of the last subject up to 2 years
Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK
次要结局
- Effectiveness evaluation(At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment)
研究者
TingBo Liang
Professor
Zhejiang University
研究点 (1)
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