A Clinical Study of CAR-NK Cells (CL-NK-003) in Patients With Advanced Pancreatic Cancer

Changhai Hospital1 个研究点分布在 1 个国家目标入组 9 人开始时间: 2026年2月12日最近更新: 2026年2月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Changhai Hospital
入组人数: 9
试验地点: 1
主要终点: Number of participants with abnormal clinical laboratory parameters reported as TEAE

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.

详细描述

A fixed-dose study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-003) in patients with locally advanced, metastatic, or recurrent 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

•1. Aged 18-75 years;
•Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate >40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;
•At least 1 measurable lesion according to RECIST 1.1;
•Have not received anti-tumor treatment for at least 4 weeks;
•ECOG performance status of 0-2;
•Estimated life expectancy more than 12 weeks;
•Hematology: neutrophils ≥ 1.5×10^9/L, lymphocytes ≥ 0.8×10^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10^9/L;
•Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);
•Volunteer to participate in this clinical study and willing to sign written informed consent.

排除标准

•1. Evidence of central nervous system involvement;
•Have received adoptive cell therapy;
•Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;
•Vaccinated with a live attenuated vaccine within 3 months;
•History of immunodeficiency;
•Active autoimmune disease;
•Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg/day (or equivalent) on any day;
•Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG/PCI; myocardial infarction/unstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction < 50%, or poorly controlled hypertension within 6 months; QTc interval > 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/ICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);
•Possible severe adverse events, allergy or other contraindications to drugs or its component under study;
•Pregnant or lactating women;
•History of neurological or psychological disorders;
•Not suitable to participate this clinical study judged by the investigator.

研究组 & 干预措施

CL-NK-003

Experimental

Fixed-dose for at least 6 patients

干预措施: CL-NK-003 (Biological)