Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer.

Exploratory Clinical Study of Combined Claudin18.2-Targeted Activated DC and CAR-T Therapy in Patients With Advanced Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Pancreatic Cancer
• Intervention / Treatment: Biological: Claudin18.2 Targeted Activated Dendritic Cells; Biological: Claudin18.2 Targeted CAR-T Cells

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: HAIFENG LIN; Phone Number: +86-13322060949; Email: 13322060949@163.com

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan Cancer Hospital
      • Contact: HAIFENG LIN; Phone Number: 13322060949; Email: 13322060949@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, upper limit ≤ 80 years, gender not limited;
2. 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).
3. Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+; expression range ≥ 50%);
4. Meeting the indications for PBMC collection and having no other contraindications for cell collection;
5. Failure of standard second-line treatment or lack of a standard treatment regimen; or signing a refusal to undergo chemotherapy.
6. ECOG score: 0-1;
7. Life expectancy: ≥ 3 months;
8. 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;

9. Sufficient organ function, including:

   1. 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.
   2. 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) < 1.5.

10. Individuals of fertility must be willing to use contraception;
11. Sufficient understanding and willingness to sign an informed consent form;
12. Willingness to comply with visit schedules, medication plans, laboratory tests, and other trial procedures.

Exclusion Criteria:

1. Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc.

2. Significant cardiovascular disease, such as:

   1. • 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;
   2. • Clinically significant QT interval prolongation (QTcF > 470ms for women or QTcF > 450ms for men).
3. Clinically significant bleeding tendency or coagulation disorders, such as hemophilia;
4. HIV infection, syphilis infection, hepatitis B infection, or hepatitis C infection.
5. History of involuntary custody due to mental illness or other mental illness deemed unsuitable for treatment by the treating physician;
6. Accompanied by other autoimmune diseases, or long-term use of immunosuppressants or steroids;
7. Poor patient compliance as assessed by the investigator;
8. Previous treatment with any target CAR-T within 3 months prior to this CAR-T treatment;
9. Uncontrollable active bacterial or fungal infections;
10. Other conditions deemed necessary to be ruled out by the physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Activated DC and CAR-T Combination Therapy	Biological: Claudin18.2 Targeted Activated Dendritic Cells; Autologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain; Biological: Claudin18.2 Targeted CAR-T Cells; Autologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Incidence and severity of adverse events	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1	2 years
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	2 years
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	2 years
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.	1 month

Collaborators and Investigators

• Sponsor: Hainan Cancer Hospital
• Collaborators: Frontiergate Biopharm（Hainan） Co., LTD
• Investigators: Principal Investigator: HAIFENG LIN, Hainan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2026
• Primary Completion (Estimated): February 18, 2028
• Study Completion (Estimated): August 18, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EC-2026-005-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request.

The data will be available beginning 6 months and ending 5 years following publication.

Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.

• IPD Sharing Time Frame: Beginning 6 months after publication and ending 5 years following publication.
• IPD Sharing Access Criteria: Access will be granted to researchers with a sound scientific proposal after review and approval, and with a signed data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No