NCT07416240招募中早期 1 期
Exploratory Clinical Study of Combined Claudin18.2-Targeted Activated DC and CAR-T Therapy in Patients With Advanced Pancreatic Cancer
Hainan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月18日最近更新:
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2 Targeted Activated DC combined with CAR-T therapy in patients with Advanced Pancreatic Cancer.
This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, upper limit ≤ 80 years, gender not limited;
- •Participants must have a histologically or cytologically confirmed diagnosis of advanced pancreatic cancer, with at least one measurable lesion meeting RECIST v1.1 criteria (i.e., a target lesion with a longest diameter ≥10 mm on spiral CT scan, or a lymph node with a short axis ≥15 mm).
- •Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+; expression range ≥ 50%);
- •Meeting the indications for PBMC collection and having no other contraindications for cell collection;
- •Failure of standard second-line treatment or lack of a standard treatment regimen; or signing a refusal to undergo chemotherapy.
- •ECOG score: 0-1;
- •Life expectancy: ≥ 3 months;
- •Toxic reactions from previous chemotherapy and other anti-tumor treatments must be resolved through a washout period (except for residual hair loss), ensuring that all functional parameters meet the inclusion criteria;
- •Sufficient organ function, including:
- •Sufficient immune function, i.e., absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L.
- •Sufficient hematopoietic function, i.e., platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the complete blood count examination. c) Sufficient liver function, i.e., total bilirubin (TBIL) < 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN.
- •d) Sufficient kidney function, i.e., creatinine (Cr) ≤ 1.5 × ULN. e) Sufficient coagulation function, i.e., prothrombin time (PT) or activated partial thromboplastin time (APTT) < 1.5 × ULN, and international normalized ratio (INR) < 1.
- •Individuals of fertility must be willing to use contraception;
- •Sufficient understanding and willingness to sign an informed consent form;
- •Willingness to comply with visit schedules, medication plans, laboratory tests, and other trial procedures.
排除标准
- •Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc.
- •Significant cardiovascular disease, such as:
- •A confirmed cardiovascular event within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or previous angioplasty, stent implantation, or coronary artery bypass grafting;
- •Clinically significant QT interval prolongation (QTcF > 470ms for women or QTcF > 450ms for men).
- •Clinically significant bleeding tendency or coagulation disorders, such as hemophilia;
- •HIV infection, syphilis infection, hepatitis B infection, or hepatitis C infection.
- •History of involuntary custody due to mental illness or other mental illness deemed unsuitable for treatment by the treating physician;
- •Accompanied by other autoimmune diseases, or long-term use of immunosuppressants or steroids;
- •Poor patient compliance as assessed by the investigator;
- •Previous treatment with any target CAR-T within 3 months prior to this CAR-T treatment;
- •Uncontrollable active bacterial or fungal infections;
- •Other conditions deemed necessary to be ruled out by the physician.
研究组 & 干预措施
Targeted Activated DC and CAR-T Combination Therapy
Experimental
干预措施: Claudin18.2 Targeted Activated Dendritic Cells (Biological)
Targeted Activated DC and CAR-T Combination Therapy
Experimental
干预措施: Claudin18.2 Targeted CAR-T Cells (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 2 years
Incidence and severity of adverse events
次要结局
- Objective Response Rate (ORR)(2 years)
- Disease Control Rate (DCR)(2 years)
- Progression-free survival (PFS)(2 years)
- Changes in the Immune Microenvironment(1 month)
研究者
研究点 (1)
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