NCT06478459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 Intratumoral NKG2D CAR-NK Cell Injection Guided by EUS in the Treatment of Locally Advanced Pancreatic Cancer.
Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6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
- 20
- 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 intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced 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
- •18~75 years old (including boundary value), both male and female.
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
- •Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient's refusal of surgery are also eligible for enrollment.
- •ECOG PS score of 0-
- •At least 3 months of life expectancy at screening, as judged by the investigator.
- •Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, and there should be no ongoing supportive care ("jaundice relieve" therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct). a) Blood biochemistry: serum creatinine ≤ 1.5×ULN, serum total bilirubin ≤ 2.0×ULN, and serum liver aminotransferase ≤ 3 ×ULN b) Blood tests: neutrophil count ≥ 1.5×109/L, platelet count ≥ 60×109/L, hemoglobin ≥ 8.0g/dL, lymphocyte count ≥ 0.4×109/L;
- •Childbearing status: not pregnant and, if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form until 6 months after the last cell infusion (women of childbearing potential include premenopausal women and women within 2 years of postmenopausal time).
- •Subjects must sign a written informed consent form.
- •Subjects must be voluntary and able to comply with the scheduled treatment regimen, laboratory tests, follow-up, and other study requirements.
排除标准
- •Pregnant and lactating females.
- •Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
- •In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to 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 by the judgment of the investigator would preclude participation in the study.
研究组 & 干预措施
CAR-NK：intratumoral injection combined with intravenous infusion
Experimental
干预措施: CAR-NK (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)
- Cell continued survival time in vivo(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)
Loading locations...
相似试验
招募中
早期 1 期
A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic CancerPancreatic Cancer Non-resectableNCT06503497Zhejiang University30
Unknown
1 期
To Evaluate the Clinical Study of CUD005 Injection in Patients With CirrhosisCirrhosis, LiverNCT06296095Anhui Provincial Hospital9
招募中
1 期
Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell LymphomaB-cell MalignancyNCT05106946Fundamenta Therapeutics, Ltd.20
招募中
1 期
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell LymphomaB-cell MalignancyNCT05106907Fundamenta Therapeutics, Ltd.20
招募中
1 期
Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urologic NeoplasmsCD70-positive Advanced Urologic NeoplasmsNCT05990621Changhai Hospital60