Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

First-in-human interleukin-15-transpresenting Wilms’ tumor protein 1-targeting autologous dendritic cell vaccination in cancer patients

This research study is investigating a new type of vaccine for people with advanced cancers, such as those affecting the pancreas, oesophagus, liver, or ovaries. These are cancers that have either returned, spread, or not responded to initial treatments. The vaccine is unique because it uses your body's own immune cells, called dendritic cells, which are specially trained to recognise and fight cancer cells. It's designed to target a specific protein found on many cancer cells. This is an early-stage study (Phases I and II) to first check if the vaccine can be made reliably and safely. Researchers will also look at how patients tolerate the treatment, any side effects, and how it might impact the cancer and the body's immune response. The goal is to see if this new approach could be a promising future treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Antwerp University Hospital

Enrolment target

Start

04 Nov 2024

Histologically or cytologically confirmed solid tumor of the pancreas esophagus liver or ovaries that is advanced recurrent or progressing after at least first-line anti-cancer treatment or for which no alternative standard therapy is available due to intolerance to or refusal of standard-of-care treatment

What is this study about?

This study is looking into a brand new type of treatment for certain advanced cancers. These include cancers of the pancreas, oesophagus, liver, or ovaries, especially when they have come back, spread, or haven't responded well to standard treatments. Sometimes, cancer treatments can cause difficult side effects, or there might not be a standard treatment available. This study aims to help patients in these situations.

The treatment is a special vaccine that uses your own immune system to fight cancer. Here's how it generally works: a small amount of your blood is taken, and a specific type of immune cell called a dendritic cell is collected. These cells are like the 'generals' of your immune system, teaching other immune cells how to recognise and attack harmful invaders. In this study, these dendritic cells are specially prepared in the lab to teach your immune system to recognise and target a protein called WT1, which is often found on cancer cells. Once ready, this personalised vaccine is given back to you.

This is a 'first-in-human' study, meaning it's one of the first times this specific vaccine is being tried in people. The main goals are to check if it's possible to successfully make the vaccine for each patient, if it's safe to give, and what side effects it might cause. Researchers will also carefully watch to see if the vaccine helps the body's immune system fight the cancer and how it might affect the cancer itself, as well as your general well-being and quality of life.

Key takeaways

This study is testing a new personal vaccine for certain advanced cancers.
It uses your own immune cells to create a tailored treatment.
The main aims are to test its safety and if it can be successfully produced.
It's an early-stage study, so the long-term benefits are not yet fully known.
You will have regular medical check-ups if you participate.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.

You must have a confirmed diagnosis of certain advanced cancers. These include cancers of the pancreas, oesophagus, liver, or ovaries. Your cancer needs to be advanced, meaning it has spread or come back, or it's not improving with typical treatments. It's also for people who can't have standard treatments or have decided not to.

There will be other medical checks to make sure your general health is suitable for this type of treatment and that it's safe for you to take part. Your doctor will discuss all the specific requirements with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced pancreatic, oesophageal, liver, or ovarian cancer?
Has your cancer progressed or come back after previous treatments?
Are you unable to receive standard cancer treatments or have chosen not to?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, the first step is a special blood collection process called 'leukapheresis'. This is similar to donating blood, but it specifically collects the immune cells needed for the vaccine. Your blood is taken through a needle in one arm, filtered through a machine to collect the cells, and then returned to your other arm. This usually takes a few hours.

After your cells are collected, the unique vaccine will be made in a laboratory. Once it's ready, you will receive the vaccine. We don't have details on the exact number of vaccine doses or how often they will be given, but you will have a clear schedule. Throughout the study and for a period afterwards, you will have regular visits to the hospital or clinic. These visits will involve check-ups, blood tests, and scans to monitor your health, look for any side effects, and see how the treatment is affecting your cancer. The total duration of your participation, including follow-up, will be explained fully by the study team.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as gaining access to a new treatment approach that isn't yet widely available, and it could potentially help teach your body to fight the cancer. However, as this is an early-stage study, the full effects and benefits are not yet known. Like all medical treatments, there are potential risks and side effects. These could be related to the blood collection procedure or the vaccine itself. The research team will carefully monitor you for any side effects and will explain all known risks before you decide to take part. It's very important to remember that joining a clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What kind of cancer is this study for?

This study is for advanced pancreatic, oesophageal, liver, or ovarian cancers that have progressed, come back, or haven't responded to initial treatments.

What is leukapheresis?

It's a procedure similar to donating blood where specific immune cells are collected from your blood to make the personalised vaccine.

Is this vaccine a standard treatment?

No, this is an experimental vaccine in an early-stage clinical trial (Phases I and II). It's not a standard treatment yet.

What are the main goals of this study?

The main goals are to see if the vaccine can be successfully made for patients, if it's safe, and what side effects it might cause.

Will I know if the vaccine is working?

The study team will monitor your cancer and immune system to see how your body responds to the vaccine, and they will share this information with you.