A Single-Arm Investigator-Initiated Tria (IIT) Evaluating the Safety and Preliminary Efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in Patients With Unresectable Pancreatic Cancer（NeuMed-uPC）
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer
研究概览
简要总结
The goal of this clinical trial is to learn if Autologous Drug-Loaded Neutrophils (NeuMed) can treat patients with Unresectable Pancreatic Cancer. The drug carried by the Autologous Neutrophils is Monomethyl Auristatin E. The main questions it aims to answer are: First, to verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer. Second, to assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer.
详细描述
In this open, single-armed study, selected patients with Unresectable Pancreatic Cancer confirmed by Histopathology will be received Autologous Drug-Loaded Neutrophils (NeuMed)-based therapy. Neutrophils will be isolated using a blood cell separator and cultured in a GMP-compliant laboratory to prepare neutrophil biological agents, which will then be loaded with the anti-tumor peptide, Monomethyl Auristatin E (MMAE).
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
- •18-70 years
- •Obtain an informed consent form voluntarily signed by the patient themselves
- •patients with Unresectable Pancreatic Cancer confirmed by Histopathology
- •Patients who either: 1) have received standard first-line treatments, proven ineffective or causing intolerable adverse effects; or 2) have not received the standard first-line treatments and voluntarily opt for Autologous Drug-Loaded Neutrophils (NeuMed)-based therapy
- •EOCG score ≤ 2 and expected survival time ≥ 3 months
- •Liver, kidney and bone marrow functions are basically normal
排除标准
- •Patients who required anti coagulant therapy
- •Patients with active infectious diseases or a history of bone marrow or organ transplantation
- •Patients with autoimmune diseases or autoinflammatory diseases
- •Patients with a history of severe cardiovascular or cerebrovascular diseases or interstitial lung disease or non-infectious pneumonia
- •Patients who have received live vaccines within 30 days prior to enrollment
- •Patients with no response to bone marrow mobilization
- •Other patients deemed unsuitable for enrollment by the investigator
结局指标
主要结局
To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer
时间窗: 12 months
Incidence rate of Adverse Events（For the grading of treatment-related adverse events, all cases were classified with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)）. Developed by the National Cancer Institute (NCI), the Common Terminology Criteria for Adverse Events (CTCAE) is currently the most widely used adverse event (AE) grading system, applicable to oncology clinical trials. It classifies adverse events into 5 grades:Grade 1 (Mild): Asymptomatic or mild in severity, with no requirement for intervention;Grade 2 (Moderate): Requiring medical intervention and causing mild impairment of daily activities;Grade 3 (Severe): Resulting in significant functional impairment, necessitating hospitalization or substantial medical intervention, and rendering the patient unable to perform daily activities;Grade 4 (Life-threatening): Pose a threat to life and require urgent intervention;Grade 5 (Death): Directly caused by the adverse event.
次要结局
- To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer(12 months)
研究者
Lin Wang
Professor
The First Affiliated Hospital of Air Force Medicial University