
"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 by itself and in combination with nivolumab.
It is open to people with melanoma that has either:
We know from research that cancer cells have changes () in the
of the
that aren’t found in healthy cells. Some of these changes are on the surface of the cancer cell. The immune system can recognise some of the 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 melanoma and your blood. The aim of ATL001 is to help your
recognise more of these changes on the surface of your cancer cells so they can be attacked.
There are 3 treatment groups in this study:
Which group you go into depends on when you join the study and on your . Your doctor will discuss this with you.
Nivolumab is also an immunotherapy. Doctors use nivolumab to treat advanced melanoma and melanoma that has come back after treatment. Nivolumab 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 main 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.
Please note, there are 3 treatment groups. Each group has specific entry conditions and we haven’t listed them all. Your doctor will know what they are. The entry conditions below apply to everyone regardless of the treatment group you are in. |
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 melanoma tissue that the surgical team can remove 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 need up to 40 worldwide. Everyone who is able to will have ATL001 treatment.
To make ATL001
You have surgery to remove the melanoma 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 melanoma 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 immune cells 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 may stay in hospital so the nurses can monitor you. This is because the treatment will have weakened your immune system 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 treatment with Interleukin-2 (IL-2). IL-2 helps immune cell growth and activity so it will help the ATL001 cells to work properly.
You will need to stay in hospital for up to 2 weeks after receiving ATL001.
There are 3 treatment groups in this study.
Group A
You have fludarabine and cyclophosphamide a week before ATL001. You then have ATL001 by itself. This is followed by daily injections of the standard, low dose IL-2 for 10 days, just under this skin. This is called a subcutaneous injection.
Group B
You have nivolumab as a drip into a vein 1 to 2 weeks before ATL001. You then have fludarabine and cyclophosphamide. This is followed by ATL001 and the standard, low dose IL-2 injections for 10 days.
You have nivolumab again 2 weeks after ALT001. You then continue to have nivolumab every 4 weeks for up to a year after having ATL001. This is as long as it is helping and the side effects aren’t too bad.
Group C
You have fludarabine and cyclophosphamide a week before ATL001. You then have ATL001 by itself. This is followed by 6-doses of a higher dose of IL-2. You have IL 2 as a drip into a vein. This group is not yet recruiting.
Samples for research
You give blood samples during the study. Researchers will use these samples to look for substances in the blood that might show how well the ATL001 is working.
The team will ask for samples of melanoma tissue during the study. They will compare these samples to the samples of tissue taken before your treatment. This is to look for any differences between the 2 tissue samples that might have happened since the ATL001 treatment.
You don’t have to agree to have these samples taken. Your doctor will tell you more about this when you join the study.
You see the doctor to have some tests before taking part and to see if you can join the study. These include:
You see the doctor a few times before you have chemotherapy and before you have nivolumab (if applicable). This is to see how you are, to check you can still join the study and for blood tests. At some of these hospital visits they repeat a few of the tests above and do other tests. They’ll tell you which tests you need to have done again and about any new tests.
You have the first couple of chemotherapy treatments on the day care or outpatient ward. On the last day of chemotherapy, you may be admitted into hospital. You then have ATL001 and will 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 have extra tests at some of the visits. Your doctor will tell you more about these.
You have a scan:
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 nivolumab 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 awhile. 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 Samra Turajlic
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.”