Phase II/III trial of autologous dendritic cells loaded with allogenic mesothelioma lysate in patients with borderline resectable pancreatic cancer

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What is this study about?

The study focuses on patients with borderline resectable pancreatic cancer, a form of cancer that is found near important blood vessels and may be removable with surgery after treatment. After receiving the standard chemotherapy combination called FOLFIRINOX, participants will be given an experimental therapy known as MesoPher. MesoPher is a personalized product made from the patient’s own immune cells called autologous dendritic cells that are loaded with broken‑down material (lysate) from cancer cells; it is given by an intravenous infusion, meaning it is delivered through a vein.

The purpose of the study is to determine whether this cell‑based therapy can improve how long patients live without the disease getting worse and ultimately increase overall survival. After the chemotherapy course, the cell infusion is administered, followed by surgery to remove the tumor when possible. Patients are then monitored over time to see if the cancer returns, using imaging criteria called RECIST 1.1, and to assess quality of life and safety. The follow‑up period includes regular doctor visits, scans, and blood tests to track the immune response and any side effects.

1 enrollment and consent

after agreeing to participate, the patient signs the consent form and is officially entered into the study.

2 baseline assessments

initial blood samples are taken to evaluate immune status.

imaging studies (such as CT scans) are performed to document the extent of the cancer.

questionnaires about quality of life are completed.

3 folfirinox chemotherapy

the patient receives the chemotherapy regimen known as folfirinox.

the chemotherapy is given in cycles; the exact number of cycles and interval between them follow the study protocol.

each cycle may include several drugs given by infusion, but the specific schedule is defined by the treating team.

4 autologous dendritic cell therapy

after completing the chemotherapy phase, the patient receives the investigational product called autologous dendritic cells loaded with allogenic lysate of mesothelioma cell lines (also referred to as mesopher).

the product is administered as an intravenous infusion of 25000000 units per infusion.

the frequency and total number of infusions are determined by the study protocol; these details are not specified in the provided information.

5 post‑treatment monitoring

regular blood draws are performed to assess immune responses and safety.

repeat imaging is scheduled to check for disease progression or recurrence.

the patient completes quality‑of‑life questionnaires at designated visits.

any adverse events are recorded and evaluated.

6 long‑term follow‑up

the patient continues to be monitored for overall survival and disease‑free survival until the end of the study period.

follow‑up visits may occur at defined intervals as outlined in the study protocol.

Who Can Join the Study?

Have a diagnosis of ABC borderline resectable pancreatic cancer that has been confirmed by a tissue sample (either a biopsy or a cell test).
The cancer must be considered either borderline resectable or clearly resectable according to the DPCG criteria, which are the doctors’ guidelines for deciding if the tumor can be removed by surgery.
Blood test for the tumor marker CA‑19.9 must be 500 kU/L or lower at the time of screening, unless the doctor has seen a clear drop in this level after prior chemotherapy (FOLFIRINOX) or the patient does not produce CA‑19.9 at all but shows no disease progression on a PET‑CT scan.
Must have completed or be currently receiving the chemotherapy regimen called FOLFIRINOX and shown a valid reduction in the CA‑19.9 level, as judged by the treating physician.
Laboratory results must show:
- Liver enzymes (ASAT/ALAT) less than five times the normal upper limit.
- Bilirubin less than 1.5 times the normal upper limit.
- Lactate dehydrogenase (LDH) within the normal range.
- Albumin (a protein in the blood) higher than 30 g/L.
Blood counts and organ function must be adequate:
- Absolute neutrophil count greater than 1.0 × 10⁹/L (a type of white blood cell).
- Total white blood cell count at least 3.0 × 10⁹/L.
- Platelet count greater than 100 × 10⁹/L (cells that help blood clot).
- Kidney function measured by eGFR (estimated glomerular filtration rate) of 50 mL/min or higher.
- Hemoglobin level higher than 6.0 mmol/L (a measure of the blood’s ability to carry oxygen).
Must be able to undergo the planned surgery.
Age must be 18 years or older and you must be able to give written informed consent, meaning you understand the study and agree to take part.
Must have a WHO performance status of 0 or 1, which means you are fully active or able to carry out light work without significant limitation.
Women who could become pregnant must have a negative pregnancy test and agree to use an effective birth‑control method (such as an intrauterine device, hormonal pills, implants, patches, or agreed‑upon abstinence) during the study and for at least 12 months after the last dose.
Men must agree to use an effective birth‑control method (such as condoms or a vasectomy) during the study and for at least 12 months after the last dose.
Must be able to travel back to the hospital for the required follow‑up visits.
Must agree to follow the study procedures outlined in the informed consent document, which follows international standards for clinical research (ICH‑GCP).

Who Cannot Join the Study?

Metastatic or locally advanced (unresectable) pancreatic cancer – cancer that has spread to other parts of the body or cannot be removed by surgery, according to the DPCG criteria.
Resectable pancreatic cancer with CA19-9 < 500 kU/L – if the tumor can be removed but the blood marker CA19-9 (a protein that can be high in pancreatic cancer) is below 500 kU/L, unless special exception rules apply.
Additional active cancer – any other cancer that is getting worse or needed treatment in the past two years (skin cancers like basal or squamous cell carcinoma that were cured are allowed).
Active autoimmune disease requiring systemic treatment – a disease where the body attacks itself (such as lupus or rheumatoid arthritis) that needed medicines affecting the whole body (like disease‑modifying drugs, steroids, or other immune‑suppressing drugs) in the past two years. Simple hormone replacement (e.g., thyroxine, insulin) is allowed.
History of non‑infectious pneumonitis needing steroids – past lung inflammation not caused by infection that required steroid medication, or having current pneumonitis.
Active infection needing systemic therapy – any infection that currently requires treatment with medicines that work throughout the whole body.
Known HIV infection – having the human immunodeficiency virus.
Known Hepatitis B or active Hepatitis C infection – having Hepatitis B surface antigen present or an active Hepatitis C virus infection.
Active or untreated syphilis – a sexually transmitted infection that has not been properly treated.
Any condition, treatment, or lab abnormality that could confuse the study results – any health problem or test result that might make it hard to understand the trial’s outcomes or that could put the participant at risk, as judged by the doctor.
Psychiatric or substance‑abuse disorders – mental health or drug/alcohol problems that would interfere with following the trial’s rules.
Pregnant, breastfeeding, or planning to conceive – being pregnant, nursing a baby, or intending to become a parent during the study or for 12 months after the last dose.
Progressive disease during neoadjuvant FOLFIRINOX – if the cancer gets worse (according to RECIST imaging criteria) while receiving the chemotherapy regimen called FOLFIRINOX.
CA19-9 response failure during neoadjuvant FOLFIRINOX – if the CA19-9 level does not drop or stays above 500 kU/L at screening, unless special exception rules apply.
History of allogeneic tissue or solid‑organ transplant – having received a donor organ or tissue.
Ampullary or distal bile duct cancer – cancers arising in the small opening where the pancreas meets the intestine (ampulla) or in the lower part of the bile duct.
Severe systemic disorders – serious whole‑body illnesses that could make the study unsafe or prevent completion, as decided by the investigator.
Positive pregnancy test at screening – a urine (or confirmatory blood) test showing pregnancy.
Current or previous use of autologous dendritic‑cell therapy or anti‑tumor vaccines – having already received your own immune‑cell therapy or cancer vaccines.
Allergy or hypersensitivity to the study drug or its ingredients – known severe reaction to the medication being tested or any of its components.
History of life‑threatening toxicity from prior immune therapy – previously experiencing a dangerous side‑effect from immune‑based cancer treatment that could not be managed.
Current use of steroids or other immunosuppressive agents – taking medicines that suppress the immune system; these must be stopped at least six weeks before the trial and not used during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Ldlik Udtjsdnbxjgc Mevdqhr Caiwhob (bwzlt	Leiden	The Netherlands
Azyxrnowy Uqk	Amsterdam	The Netherlands
Eanhwle Ujrbjkdipvah Mfoqqnq Cgoqyiq Rhthfziql (hyrsguh Mnx	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

AUTOLOGOUS DENDRITIC CELLS LOADED WITH ALLOGENIC ALLOGENEIC LYSATE OF MESOTHELIOMA CELL LINES

MesoPher is a personalized cell‑based therapy that uses a patient’s own immune cells called dendritic cells. In the laboratory, these dendritic cells are loaded with proteins (lysate) taken from mesothelioma cancer cell lines. When the treated cells are given back to the patient through an intravenous infusion, they help the immune system recognize and attack cancer cells in the pancreas. The goal of the therapy in the trial is to improve how long patients live without the cancer getting worse (progression‑free survival) and ultimately to increase overall survival. This treatment is considered an immunostimulant and is designed especially for people with borderline resectable pancreatic cancer.

Borderline resectable pancreatic cancer – Borderline resectable pancreatic cancer is a form of pancreatic cancer in which the tumor has grown close to major blood vessels but may still be removed by surgery. The disease often begins with a small growth in the pancreas that can cause mild abdominal discomfort. Over time the tumor can extend to surrounding tissues and lymph nodes, making surgery more difficult. If it continues to grow, it may become unresectable and spread to other parts of the body.

Trial ID:

2025-523134-28-00

Protocol code:

14395

Trial Phase:

Therapeutic use (Phase IV)

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Phase II/III trial of autologous dendritic cells loaded with allogenic mesothelioma lysate in patients with borderline resectable pancreatic cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?