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.
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;
Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc.
• 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;
Single group
Claudin18.2 Targeted Activated Dendritic Cells
Biological/VaccineAutologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain
Claudin18.2 Targeted CAR-T Cells
Biological/VaccineAutologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR)
Adverse Events (AEs)
Incidence and severity of adverse events
Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Disease Control Rate (DCR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1
Progression-free survival (PFS)
PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause
Changes in the Immune Microenvironment
Assess the changes in the tumor immune microenvironment before and after subjects received combined therapy with Claudin18.2 targeted activated dendritic cells (DCs) and CAR-T cells.
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Hainan Cancer Hospital
Lead sponsor
Frontiergate Biopharm（Hainan） Co., LTD
Collaborator
