
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at a type of called ATL001 for non small cell lung cancer (NSCLC).
It is open to people with non small cell lung cancer that has either:
We know from research that cancer cells have changes () in the
of their
that aren’t found in healthy cells. Some of these changes are on the surface of the cancer cell. The
can recognise some of these surface changes but not well enough to control the cancer.
ATL001 is a type of immunotherapy called . ATL001 is made in the laboratory using immune cells taken from a sample of your non small cell lung cancer (NSCLC) and your blood. The aim of ATL001 is to help your immune system recognise more of these changes on the surface of the cancer cells so they can be attacked.
There are 2 treatment groups in this study. Group A has ATL001 treatment by itself. Group B has ATL001 treatment combined with pembrolizumab treatment.
Pembrolizumab is also an . Doctors use pembrolizumab to treat NSCLC. Pembrolizumab works by helping the immune system find and attack cancer cells.
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.
There are 2 treatment groups in this study. There are certain entry conditions for each group and reasons why you might not be able to join one of the groups. We haven’t listed them all. Your doctor will know what they are. The entry conditions below apply to everyone. |
Who can take part
You may be able to join this study if all of the following apply. You:
There must also be enough of the lung cancer tissue that the surgical team can take a sample from to make the ATL001. Your doctor will know if there is enough.
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 an international phase 1/2 study. The team needs up to 50 people worldwide to join.
Everyone who is able to will have ATL001. Some people will also have pembrolizumab. Your doctor will tell you if you are having pembrolizumab.
To make ATL001
You have surgery to remove a sample of the NSCLC tissue. You also give a blood sample at the same time or at a later date if needed. The team use both these samples to make ATL001 in the laboratory. It takes about 3 months to make ATL001. While waiting you may continue to have the for NSCLC if your doctor thinks this is best for you.
You might need to return to give another blood sample if for some reason the first sample couldn’t be used to make ALT001.
Having ATL001
A week before having ATL001 you have fludarabine and cyclophosphamide chemotherapy. You have this once a day for 3 days through a drip into your vein. These treatments are not meant to treat your cancer but are used to lower the number of in your body. This is to make room for ATL001 when you have it. This helps the ATL001 cells to survive and work correctly.
On the 3rd day of treatment you stay in hospital so the nurses can monitor you. This is because the treatment will have weakened your making it more likely for you to get an infection.
About 4 days after finishing chemotherapy you have ATL001 through a drip into your vein. You have 1 day of ATL001 treatment.
Within 3 to 12 hours after ALT001 treatment, you start injections of low dose Interleukin 2 (IL-2). You have it once a day for 10 days. You have IL-2 as an injection just under the skin This is called a subcutaneous injection. IL-2 helps immune cells to grow and how they work. This will help the ATL001 cells to work properly.
You stay in hospital for up to 2 weeks.
People having pembrolizumab
As well as having ATL001, some people also have pembrolizumab. You have pembrolizumab as a drip into a vein. You have pembrolizumab:
You have pembrolizumab for up to a year as long as it is helping and the side effects aren’t too bad.
Samples for research
You give blood samples during the study. Where possible the team take these when you have your routine blood tests.
Researchers use these samples to look for substances in the blood () that might show how well the treatment is working.
The team ask for samples of tissue (biopsies) during the study. Your doctor will tell you more about this and when they will take the samples. You don’t have to agree to have these tissue samples taken.
You see the doctor for tests before taking part in the study. These tests include:
You see the doctor a few times before you have fludarabine and cyclophosphamide. If you are having pembrolizumab you see the doctor a few times before having it. This is to see how you are, to check you are still able to take part in the study and for blood tests. At some of these hospital visits, they repeat some of the tests you had before and do other tests. They’ll tell you which tests you need to have done.
You have the first 2 days of treatment on the day care ward or outpatient ward. On the 3rd day you go into hospital where you have the rest of your treatment before having ATL001. You then have ATL001. You stay in hospital for up to 2 weeks.
After leaving hospital you see the doctor at:
This is for blood tests and to see how you are. You may also need extra tests at some of these visits. Your doctor will tell you more about these.
You have a CT scan or MRI scan after having ATL001:
If a scan shows your cancer might have got worse or spread you have another scan 4 weeks later. If this scan confirms your cancer has got worse or spread you have no more scans for the study.
You stay in hospital for up to 2 weeks. This is so the team can monitor you for any side effects that you might have. You might have to stay in the hospital longer if your side effects are quite bad.
After leaving hospital contact the hospital advice line or tell your doctor or nurse if any side effects are:
ATL001 and pembrolizumab can affect the ![]() ![]() If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
ATL001 is a new treatment and there might be side effects that we don’t know about. While you are having ATL001, your nurse will watch you closely to check for signs of an allergic reaction. If there are signs they will slow down the drip. Or they might stop it for a while. Side effects of ATL001 can include:
We have information about:
Your doctor will talk to you about the possible side effects of all the treatments used in this study 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.
Dr Martin Forster
Achilles Therapeutics
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”