Claudin18.2-targeted activated dendritic cell plus CAR-T therapy for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm early-phase 1 trial combines Claudin18.2-targeted activated dendritic cells with Claudin18.2-specific CAR-T cells to test safety and early signs of benefit in advanced pancreatic cancer. The approach uses patient-derived PBMCs to produce activated DCs intended to reshape the tumor immune microenvironment and CAR-T cells that target Claudin18.2-positive tumor cells. Eligible participants must have histologically confirmed advanced pancreatic cancer, measurable disease by RECIST v1.1, and tumor Claudin18.2 expression of ≥2+ in ≥50% of cells. The study is conducted at Hainan Cancer Hospital and includes monitoring for adverse events, tumor response, and immune biomarkers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hainan Cancer Hospital
  Haikou, Hainan, China Recruiting

Study contacts

• Principal investigator: Haifeng Lin — Hainan Cancer Hospital
• Study coordinator: Haifeng Lin
• Email: 13322060949@163.com
• Phone: +86-13322060949

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.