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Clinical Trials in China / NCT07416240
Recruiting Phase EARLY_PHASE1

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

NCT07416240 · tracked via the Priya Life Science China tracker
Sponsor
Hainan Cancer Hospital
Phase
Phase EARLY_PHASE1
Started
2026-02-18
Last updated
2026-02-18

Condition(s) studied

Advanced Pancreatic Cancer

Investigational drug(s) / intervention(s)

Claudin18.2 Targeted Activated Dendritic CellsClaudin18.2 Targeted CAR-T Cells

Claudin18.2 Targeted Activated Dendritic Cells: Autologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain

Claudin18.2 Targeted CAR-T Cells: Autologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hainan Cancer Hospital Haikou Hainan Recruiting

More Hainan Cancer Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416240 on ClinicalTrials.gov ↗ ← All trials in China