Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of Personalized Neoantigen Specific TCR T cells in the Treatment of Advanced Solid Cancers

This study is investigating a new and highly personalised treatment for people with advanced solid cancers. It’s a bit like giving your body’s own immune system a boost to fight the cancer. Doctors will take a special type of immune cell from your body, called a T-cell, and train it in the lab to recognise and attack your specific cancer cells. Once trained, these T-cells will be given back to you. This is a very early study, called a Phase I trial. This means it’s one of the first times this treatment is being given to people. The main aim is to check if it's safe and to see what effects it has on the body. We call this 'personalized' because the treatment is tailored specifically to your cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Neogene Therapeutics B.V.

Enrolment target

Start

02 Dec 2024

Advanced Solid Cancers

What is this study about?

This study is about a new and clever way to treat advanced solid cancers. 'Advanced solid cancers' means cancers that have grown or spread, and are not blood cancers like leukaemia. This treatment is highly personalised, which means it's made just for you.

Here's how it works: your body has special defence cells called T-cells that are part of your immune system. They usually find and fight off infections. In this study, doctors will take some of your T-cells and teach them how to recognise and destroy your specific cancer cells. They do this by looking for unique markers on your cancer cells, called 'neoantigens'. Think of these markers as a 'wanted' poster for your cancer. The T-cells are then trained to spot these posters.

Once these specially trained T-cells are ready, they will be given back to you. The idea is that these boosted T-cells will then hunt down and kill the cancer cells throughout your body. This is a Phase I study, which means it’s one of the very first times this specific treatment will be tried in people. The main goal is to find out if it's safe and to learn more about how it works in the human body, rather than being focused on curing the cancer right away.

Key takeaways

Tests a new, personalized immune cell therapy for advanced solid cancers.
Uses your own T-cells trained to fight your specific cancer.
It's an early-stage (Phase I) study mainly focused on safety and how it works.
Open to adults aged 18 and over with advanced solid cancers.
Participation involves hospital visits and close monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, people need to meet certain conditions. You must have an advanced solid cancer. 'Advanced' means that either the cancer has spread, or it has come back after other treatments. The study is open to both men and women, and you must be at least 18 years old.

There might be other health requirements too, such as having certain blood test results that show your body is healthy enough for the treatment. The research team will need to check your medical history to make sure this study is safe and suitable for you. They will explain all the details clearly.

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 a type of cancer that has spread or returned (advanced solid cancer)?
Are you willing to have your blood and possibly a tissue sample (biopsy) taken?
Are you able to attend appointments at the hospital for treatment and follow-up?
Are you generally well enough for a new treatment, as assessed by a doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have a number of hospital visits. First, doctors will examine you and take blood samples and possibly a small piece of your cancer (a biopsy). This is to check if you're suitable and to help make your personalised treatment. Then, some of your T-cells will be collected, which usually involves a process similar to donating blood, where your blood is filtered. These cells are then sent to a special lab to be 'trained'.

Once your personalised T-cells are ready, you will receive them as an infusion, much like a drip. You'll then have regular check-ups, blood tests, and scans to see how you're responding and to monitor for any side effects. The total duration of your participation, including follow-up visits, will be explained by the study team, but it will likely involve several months to a year or more of continued monitoring.

Potential risks and benefits

It's important to understand that this is an early-stage study, so the potential benefits are not yet fully known. For some, the treatment might help shrink or control their cancer, but this is not guaranteed. There are potential risks and side effects, as with any new treatment. These could include reactions to the infusion, fatigue, or other immune-related effects. The study team will explain all known and possible side effects, and your safety will be closely monitored. You are always free to leave the study 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
Netherlands

Common questions

What does 'advanced solid cancers' mean?

It means cancers that have grown or spread to other parts of your body, and they are not blood cancers like leukaemia.

What are T-cells?

T-cells are special immune cells in your body that help fight off infections and diseases, including cancer. They are like your body's personal soldiers.

Is this a new type of treatment?

Yes, this is an early-stage (Phase I) study, meaning it's one of the first times this specific treatment is being explored in people. It’s quite innovative.

Will this treatment definitely cure my cancer?

No, as this is an early study, the main aim is to check safety and how the treatment works, rather than to guarantee a cure. Any benefits for cancer are still being investigated.

What does 'personalised' mean for this treatment?

It means the treatment is uniquely made for you, using your own T-cells trained to fight your specific cancer instead of a general cancer treatment.