
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
A study to find out how safe a drug called ADP-A2AFP is for liver cancer and how well it works.
It is open to people who have a liver cancer that has got worse after treatment.
In this study researchers are looking at using changed from your own body to treat cancer. T cells are a part of your
. They help fight diseases including cancer.
The study team take some T cells from your blood and change them in the lab. They change the of the T cells so that they can better recognise and fight cancer. The changed T cells are then called ADP-A2AFP.
You then have ADP-A2AFP as a drip into a vein or through a central line.
The main aims of this study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is a phase 1 study. The study team need up to 45 people to take part. There are 2 parts to this study.
In the first part the first few people taking part have a small dose of ADP-A2AFP. If they don’t have any serious side effects the next few have a larger dose. And so on until they get the best dose. This is called a dose escalation study.
In the second part everyone has the best dose of ADP-A2AFP. This is a dose expansion study.
There are 4 steps to this treatment:
Collecting the T cells
You have a thin tube () in your vein or a long line such as a
. This is connected to a machine where your blood goes through. The machine filters out certain blood cells and everything else goes back into your bloodstream. It can take up to 4 or 5 hours.
The T cells are then separated from the collected blood cells and sent to the lab.
Making ADP-A2AFP
In the lab your T cells are changed into ADP-A2AFP. This takes about a month.
It is possible the lab staff might not be able to change your T cells. In this case your doctor will talk about the options available. One option might be you have another blood collection done.
Chemotherapy before ADP-A2AFP
You have chemotherapy during the week before ADP-A2AFP. You have:
You have them as a drip into a vein or through a central line. You have chemotherapy for 3 or 4 days.
The day after you finish your chemotherapy you have G-CSF. You have this as an injection under the skin.
You can have chemotherapy as an inpatient in the hospital or as a day patient in the outpatient department. Your doctor will talk to you about this and you both can decide which is best.
Having ADP-A2AFP
The ADP-A2AFP you have is made from your own T cells only.
You have your ADP-A2AFP as an inpatient in the hospital. You have ADP-A2AFP 4 or 5 days after the chemotherapy. You have it as a drip into the vein or through a central line. This takes about 15 to 30 minutes.
Before having ADP-A2AFP you have an and paracetamol to help with certain side effects. A member of the study watches you closely for 4 to 8 hours after having ADP-A2AFP for any side effects.
Research samples
You give blood samples at certain times during the study. The team use these to find out how your body is reacting to ADP-A2AFP and how it affects your body. They are also looking at how it affects substances in the blood ().
You give 3 tissue samples () from your cancer after having ADP-A2AFP. Your doctor will explain this to you. The team use these samples to help understand:
You see the doctor to have tests before taking part. These tests include:
You see the doctor before having your T cells collected (leukapheresis) to see how you are.
In the week before starting chemotherapy you see the doctor for:
During chemotherapy you see the doctor each day to see how you are.
Before having ADP-A2AFP you have a heart scan and physical examination.
After leaving the hospital you see the doctor several times in the first 6 months. You then see them every 3 months till the end of the study or your cancer starts to get worse.
You have a CT scan or MRI scan at:
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
ADP-A2AFP is a new drug and there may be side effects we don’t know about yet. Side effects that have occurred in people who had changed T cells like ADP-A2AFP include some that you should contact your doctor straight away if you have any of them. They include:
Other problems or side effects include:
And some much rarer side effects that your doctor will tell you about.
We have information about:
Your doctor or a member of the study team will talk to about the possible side effects of all the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tim Myer
Adaptimmune LLC
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”