Not recruitingRare disease

Study on WT1/IL15/IL15Ra mRNA DC Vaccine for Patients with Advanced or Refractory Solid Tumors of the Pancreas, Esophagus, Liver, or Ovaries

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of cancer, specifically those affecting the pancreas, esophagus, liver, and ovaries. These cancers are advanced, have come back, or are getting worse after initial treatments. The study is testing a new treatment called WT1/IL15/IL15Ra mRNA DC, which is a type of vaccine made from a patient's own cells. This vaccine is designed to help the immune system recognize and fight cancer cells more effectively.

The purpose of the study is to see if this new vaccine can be safely made and given to patients with these types of cancer. The vaccine is given as an injection just under the skin. Patients will receive the vaccine and be monitored to see how their bodies respond to the treatment. The study will also look at how the vaccine affects the patients' quality of life and how their cancer responds to the treatment over time.

Throughout the study, researchers will keep track of any side effects and how well the vaccine is working. The goal is to find out if this new approach can be a safe and effective option for people with these challenging types of cancer. The study is expected to continue until 2026, with the hope of providing new insights into cancer treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of a solid tumor in the pancreas, esophagus, liver, or ovaries that is advanced or recurrent.
The patient must have at least one measurable lesion and a reasonable life expectancy of at least three months.
Step 2
Leukapheresis procedure
A procedure called leukapheresis is performed to collect white blood cells from the patient. This is necessary for the production of the personalized vaccine.
Step 3
Vaccine production
The collected cells are used to produce the WT1/IL15/IL15Ra mRNA DC vaccine. This process involves ensuring the vaccine meets all quality control standards.
Step 4
Vaccine administration
The vaccine is administered through an intradermal injection. The schedule and dosage are determined by the study protocol.
The primary goal is to evaluate the safety and feasibility of the vaccine administration.
Step 5
Monitoring and follow-up
The patient is monitored for any adverse effects (AEs) or serious adverse effects (SAEs) during and after the vaccine administration.
The study also assesses the clinical efficacy, including the overall response and progression-free survival.
Step 6
Quality of life assessment
Throughout the trial, the patient's quality of life is evaluated, focusing on how the therapy is experienced and how disease-related symptoms evolve.

Who can join the trial?

7 criteria

You must have a confirmed solid tumor in the **pancreas**, **esophagus**, **liver**, or **ovaries**. This means that tests have shown the presence of cancer cells in these areas.
Your cancer must be **advanced**, **recurrent**, or getting worse after at least one type of anti-cancer treatment. Alternatively, there should be no other standard treatment options available for you, either because you cannot tolerate them or you have chosen not to undergo them.
You need to have at least one **measurable or evaluable lesion**. This means there should be a tumor or area of cancer that can be measured or assessed using specific medical criteria.
You should have a **reasonable life expectancy** of at least 3 months, as determined by the doctor conducting the study.
You must be **18 years or older** at the time you agree to participate in the study.
Your **performance status** should be between 0 and 2 according to the World Health Organization (WHO) scale. This scale measures how well you can carry out daily activities.
You need to have **adequate hematologic and end-organ function**. This means your blood and major organs, like the liver and kidneys, should be working well enough to participate in the study.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with a solid tumor in the pancreas, esophagus, liver, or ovaries.
Patients whose tumors are not advanced, recurrent, or progressing after at least one anti-cancer treatment.
Patients who have alternative standard therapy options available and are not intolerant or refusing standard treatment.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not considered part of the vulnerable population selected for the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
University Of Antwerp
Edegem, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

IL-15-transpresenting WT1-targeted DC vaccine is a new type of treatment being tested in this clinical trial. It is designed to help the body's immune system fight cancer. This vaccine uses a special protein called interleukin-15 (IL-15) to help the immune system recognize and attack cancer cells. The vaccine is made from the patient's own cells, which are modified to target a specific protein found in some cancer cells, known as the Wilms' tumor protein 1 (WT1). The goal of this treatment is to see if it is safe and if it can help treat patients with advanced or hard-to-treat solid tumors.

Wt1/Il15/Il15Ra Mrna Dc

What is already known about the treatment

IL-15-transpresenting WT1-targeted DC vaccine – This medication is administered as a vaccine, specifically designed for injection. It is currently in the clinical trial phase, being studied for its safety and feasibility in treating advanced or refractory solid tumors, such as those of the pancreas, esophagus, liver, or ovaries. The main therapeutic indication is for patients with these types of tumors who have not responded to standard treatments or cannot tolerate them. The vaccine works by using dendritic cells that present interleukin-15 and target the Wilms' tumor protein 1, aiming to stimulate the immune system to attack cancer cells. It falls under the pharmacological classification of cancer immunotherapy.

Investigated diseases

Pancreatic Cancer
This is a type of cancer that begins in the tissues of the pancreas, an organ in the abdomen that lies behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As it advances, it may cause abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and lymph nodes, making it more challenging to manage. It is often diagnosed at a late stage due to its subtle early symptoms.
Esophageal Cancer
This cancer occurs in the esophagus, the long tube that carries food from the throat to the stomach. It typically begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The disease can spread to lymph nodes and other organs, complicating treatment. Early symptoms are often mild, leading to late diagnosis.
Liver Cancer
This type of cancer starts in the cells of the liver, an organ located in the upper right portion of the abdomen. It can develop from different types of liver cells, but the most common form is hepatocellular carcinoma. As it progresses, it may cause symptoms like weight loss, upper abdominal pain, and jaundice. The cancer can spread to other parts of the body, including the lungs and bones. It is often associated with chronic liver diseases such as cirrhosis.
Ovarian Cancer
This cancer begins in the ovaries, the female reproductive glands that produce eggs. It often goes undetected until it has spread within the pelvis and abdomen. As it progresses, it may cause abdominal bloating, pelvic pain, and changes in bowel habits. The disease can spread to the lining of the abdomen and other organs, making it more difficult to treat. Early-stage ovarian cancer rarely causes any symptoms, leading to late-stage diagnosis.