Active not recruitingPHASE1INTERVENTIONAL

AFPᶜ³³²T in Advanced HCC

This study is for adults aged 18-75 with advanced liver cancer or other cancers that produce a protein called AFP, which may have come back or not responded to other treatments. The main goal is to test how safe a new treatment is. This treatment involves taking a patient's own immune cells (T-cells), modifying them in a lab to target cancer, and then giving them back to the patient. Researchers also want to see what effects these specially trained T-cells have on the cancer. Participants will be carefully monitored for safety and any changes in their cancer. It's a new approach to potentially help the body fight the cancer itself.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Adaptimmune

Enrolment target

Start

08 May 2017

Estimated completion

07 Dec 2025

Hepatocellular Cancer AFP Expressing Tumors

What is this study about?

Imagine your body has its own army of defender cells, called T-cells, which usually fight off infections. In cancer, sometimes these T-cells don't recognise the cancer cells as a threat. This study is trying to give these defender cells a special 'training' to find and attack cancer.

This new treatment involves taking some of your own T-cells from your blood. These cells are then sent to a special lab where they gently change them. They teach these T-cells to spot a particular protein called AFP that is often found on the surface of liver cancer cells and some other cancers. Once these T-cells are 'trained', they are multiplied and then given back to you through a drip.

The idea is that these new, specially trained T-cells will then be able to go into your body, find the cancer cells that have the AFP protein, and destroy them. This is a very new kind of treatment, and because it's the first time it's being used in people, the main focus is to make sure it's safe. The study will also help researchers understand if and how well these modified T-cells work against the cancer.

Key takeaways

This study uses your own immune cells to fight specific cancers.
It's mainly looking at the safety of this new treatment first.
It's for advanced liver cancer or other specific AFP-producing tumours.
Participation involves cell collection, processing, treatment, and long-term follow-up.
Careful monitoring and regular check-ups are a key part of the study.
It's an early-stage trial, so outcomes are still being understood.

Who may be eligible?

This study is looking for men and women between 18 and 75 years old who have advanced liver cancer that has grown or returned after treatment, or who have another type of cancer that produces the AFP protein. You might be considered if you weren't able to have other treatments, or if those treatments didn't work, or if you chose not to have them.

To join, your blood tests would need to show a specific match in your immune system, and your cancer or blood must show enough of the AFP protein that the special T-cells are designed to target. Sometimes, the non-cancerous part of your liver is also checked to make sure it doesn't have too much of this protein.

There are also some reasons why you might not be able to join. For example, if you've had a liver transplant before, or if your immune system or other organs aren't working well enough. Your study doctor will go through all these details with you to see if you're a good fit.

Quick self-check

Are you between 18 and 75 years old?
Do you have advanced liver cancer or another cancer that produces the AFP protein?
Has your cancer come back or not responded to other treatments?
Do your blood tests show a specific immune system type (HLA-A*02 P Group positive)?
Does your cancer or blood have enough of the AFP protein?
Are you generally well enough to take part and travel for appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the first step involves taking a sample of your blood to collect your T-cells. These T-cells then go to a lab to be specially prepared, which takes about a month. During this time, you might have some chemotherapy for about three days. Once your T-cells are ready, they'll be given back to you through a drip in your arm.

After receiving your T-cells, you'll need to stay in the hospital for at least a week so doctors can watch you closely. For the next six months, you'll have frequent appointments with the study doctor. After that, you'll have check-ups every three months. If your cancer progresses or you decide to leave the study, you'll still be followed up for safety monitoring for a very long time – every six months for the first five years, and then once a year for the next ten years. The study will test different amounts of T-cells to find the safest and most effective dose.

Potential risks and benefits

Because this is a new type of treatment, the main aim is to understand its safety. While there's no guarantee, there's a potential that these specially trained T-cells could help your body fight the cancer. However, as with any medical treatment, there could be side effects or risks. Your doctors will explain all the potential risks and benefits in detail. Remember, taking part in any study is completely your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (21)

Mayo Clinic Arizona
Phoenix, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
UCLA
Los Angeles, United States
University of Miami
Miami, United States
Winship Cancer Institute - Emory University
Atlanta, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, United States
Massachusetts General Hospital
Boston, United States
Mayo Clinic Clinical Trial Referral Office
Rochester, United States
Washington University - School of Medicine
St Louis, United States
MD Anderson Cancer Center
Houston, United States
Fred Hutchinson Cancer Research Centre
Seattle, United States
SCCA Immunotherapy Trials Intake
Seattle, United States

+9 more sites — see the official record for the full list.

Common questions

What is AFP?

AFP stands for Alpha-Fetoprotein. It's a protein that can sometimes be found in higher amounts in people with liver cancer and certain other cancers.

What are T-cells?

T-cells are a type of immune cell, like tiny soldiers in your body's defence system that normally help fight off infections and diseases.

Is this a cure for cancer?

This is a very early-stage study, specifically looking at safety and initial effects. It's not yet known if it will cure cancer, but researchers hope it could be a new way to fight it.

Will I have chemotherapy?

Yes, you will likely receive a short course of chemotherapy before your specially prepared T-cells are given back to you.

How long will I be in the study?

You will be closely followed for at least 6 months, then every 3 months. For safety, long-term follow-up can last for up to 15 years.