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

A study to assess the safety and anti-tumor activity of T cell therapy in subjects with advanced liver cancer or any other AFP expressing tumor types

This research is investigating a new treatment called T-cell therapy for people who have advanced liver cancer (known as hepatocellular carcinoma) that can't be removed with surgery or a transplant. It's also open to people with other types of cancer that produce a particular protein called AFP. This is a very early-stage study, meaning it's the first time this treatment is being tested in people. The main goals are to check if the treatment is safe to use and to see if it has any effect on slowing down or shrinking the cancer. The study hopes to find a new way to help people with these challenging cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Adaptimmune LLC
Enrolment target
14
Start
26 Aug 2024

What is this study about?

This study is about a new and developing treatment called T-cell therapy. Imagine your body's immune system as an army that fights off invaders like germs and illnesses. Some cancer cells are very good at hiding from this army. T-cell therapy is a way to take a special type of immune cell, called a T-cell, from a person's blood, train it in a lab to recognise and attack cancer cells, and then give it back to the person. This is like giving your body's army a new, more powerful weapon to target cancer.

The specific type of cancer this study is focusing on is advanced liver cancer, often called hepatocellular carcinoma (HCC). This is for people whose cancer is too widespread or advanced for standard treatments like surgery or a liver transplant. It's also open to people with other types of cancer where the cancer cells produce a protein called AFP. This protein acts like a flag that the specially trained T-cells in this therapy are designed to spot.

Because this is the very first time this T-cell therapy is being given to people, it's called a 'Phase I' study. The main aim at this stage is to carefully watch for any side effects and to understand if the treatment is safe. Researchers will also be looking to see if there are any early signs that the treatment is working against the cancer. This type of research is crucial for developing new life-saving treatments in the future.

Key takeaways

  • Exploring a new T-cell therapy for advanced liver cancer and other specific cancers.
  • First time testing this treatment in humans (Phase I study).
  • Focus is on safety and early signs of anti-cancer activity.
  • Open to adults aged 18 and over, both men and women.
  • Might be an option if standard treatments for advanced liver cancer are exhausted.
  • Participation involves close monitoring for safety and results.

Who may be eligible?

This study is looking for volunteers who are aged 18 years and above, with no upper age limit. Both men and women can take part.

You might be suitable if you have advanced liver cancer (specifically hepatocellular carcinoma) that doctors have determined cannot be removed with surgery or a liver transplant. The study is also open to people with other types of cancer that produce a protein called AFP.

Even if you've had other treatments for your cancer locally (for example, treatments that target the tumour directly in the liver), you might still be able to join this study. The doctors running the study will carefully check your full medical history to make sure this study is right for 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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced liver cancer that cannot be surgically removed or transplanted?
  3. Do you have another type of cancer that produces the AFP protein?
  4. Are you able to travel to study appointments and undergo regular checks?
  5. Have you discussed this study with your doctor?
Answer every question to see your result.

What does participation involve?

We don't have all the details about what participating in this specific study involves. However, in studies like this in the early stages (Phase I), you can typically expect several visits to the hospital or clinic. These visits will be for various checks, such as blood tests, scans (like CT or MRI), and physical examinations to closely monitor your health and how you're responding.

The T-cell therapy itself will be given as an infusion, similar to a drip. Before receiving the T-cells, you might have some preparatory treatments, such as other medications to help your immune system get ready. After the treatment, you'll have regular follow-up appointments, which could last for several months or even longer, to continue monitoring your safety and health. The total duration of your active participation and follow-up will be explained by the study team.

Potential risks and benefits

Participating in a study like this means you might be among the first to receive a new treatment that could potentially help fight your cancer, especially if standard treatments haven't worked. However, because this is a new and early-stage treatment, there's always a possibility of unknown side effects, some of which could be serious. The research team will monitor you very closely for any reactions. You'll be given detailed information about all known and potential risks before you decide to take part, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

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

Common questions

What is T-cell therapy?

It's a new treatment where your own immune cells are specially trained in a lab to find and attack cancer cells, then given back to you.

Which types of cancer is this study for?

It's for advanced liver cancer that can't be treated with surgery or transplant, or other cancers that make a protein called AFP.

Why is this called a 'Phase I' study?

Phase I means it's the very first time this treatment is being tested in people. The main goals are to check if it's safe and to understand how it works.

Will I get better if I join this study?

We hope the treatment might help, but as it's a new therapy, we can't guarantee it will work. The main aim is to learn if it's safe and shows any signs of benefit.

Can I still have local cancer treatments if I join?

Yes, some local treatments for your cancer are allowed up until a certain point in the study. The study team will explain the details.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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