A trial looking at T4 immunotherapy for people with head and neck cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at using T4 immunotherapy for people with head and neck cancer who have already had standard treatment or who are unable to have standard treatment. Standard treatment is the most commonly used treatment for a particular cancer. People in this trial need to have a type of head and neck cancer that started in the squamous cells. And the cancer either needs to be locally advanced or to have come back after previous treatment.
More about this trial
T4 immunotherapy is a new cancer treatment. It works by helping a type of white blood cell called T cells attack the cancer. T cells are part of our immune system. In this trial doctors take a sample of blood. Then in the laboratory they alter the T cells from the blood sample. The changes they make to the T cells help them to recognise cancer cells and attack them. This is the T4 immunotherapy.
The doctor injects the T4 immunotherapy directly into the cancer. This is called intratumoural treatment. Some people in the trial will also have
In this study the researchers want to
- Test the safest dose of T4 immunotherapy
- See whether the treatment shrinks or controls the cancer
- See what happens to the T4 immunotherapy cells and how the immune system reacts to them
- See if giving cyclophosphamide with T4 immunotherapy is safe and helps the T4 immunotherapy to work
Who can enter
You may be able to join this trial if all of the following apply. You
- Have squamous cell head and neck cancer which is locally advanced or your cancer has come back after previous treatment
- Have already had or are unable to have standard treatment
- Have at least 1 tumour that can be injected through the skin and which can be seen and measured on either a CT or MRI scan (your doctors can advise you about this)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood results
- Are willing to use reliable contraception during treatment and for up to 3 months afterwards if there is any chance that you or your partner could become pregnant. If you are having fludarabine and cyclophosphamide you must be willing to use reliable contraception during treatment and for 6 months after
- Are at least 18 years old
You cannot join this study if any of these apply.
- Your cancer has spread to your brain (brain metastases)
- You are at risk of having problems with your airway (your doctors can advise you about this)
- Your cancer might grow into nearby major blood vessels (your doctors can advise you about this)
- You have had external radiotherapy to any of the areas which the doctors would want to inject with T4 immunotherapy
- You have had an experimental drug in the last week
- You have had any type of immunotherapy in the last week
- You have had external radiotherapy or chemotherapy in the last week
- You had steroids such as prednisolone in the last week
- You take blood thinning drugs such as warfarin
- You have any problems with your heart (your doctors can advise you about this)
- You have had your spleen removed (a splenectomy)
- You have an autoimmune disease
- You have HIV, HTLV, hepatitis B, hepatitis C or syphilis
- You have any other medical condition or mental health problem that the trial team think could prevent you taking part
- You are pregnant or breastfeeding
If you are to have nivolumab, fludarabine and cyclophosphamide as well as the above you cannot join the trial if any of these also apply. You:
- are allergic to fludarabine, cyclophosphamide or nivolumab
- have had a previous non melanoma skin cancer or melanoma skin cancer
- have a live vaccine 4 weeks or less before starting treatment, during treatment and for 3 months after having fludarabine
Trial design
This is a phase 1 trial. The doctors want up to 30 people to take part. The trial is taking place at Guy’s Hospital in London.
Everybody in the trial will have T4 immunotherapy. The dose you get will depend on when you join the trial. The doctors are aiming to have up to 5 different doses. When they know what the highest safest dose is the next group of people to join the trial will also have
When you join the trial the doctors will take a blood sample. They use this to create the T4 immunotherapy. It takes 2 weeks in a laboratory to produce the treatment.
2 weeks after they collect your blood you go into hospital for 24 hours. Immediately before you have the treatment the doctor will give you an injection of local anaesthetic to numb the area. They then inject the T4 immunotherapy directly into the cancer. The doctor might use an ultrasound scan to guide the injection. They inject it into a number of areas of the cancer.
After having the T4 immunotherapy you stay in hospital for a week.
People having fludaribne, cyclophosphamide and nivolumab
You have fludarabine and cyclophosphamide once a day for 3 days between 3 and 6 days before you are due to have the T4 immunotherapy injection.
You have nivolumab the day before having the T4 immunotherapy injection. And again at 4 weeks and 8 weeks after having the T4 immunotherapy injection.
You have these drugs as a drip into a vein. You also have extra fluid (saline) the same way. You have all this as an outpatient and it takes 8 hours. When you go home afterwards you must drink plenty of fluid. This is to make sure there is enough fluid in your body. The team will tell you how much you need to drink.
A few people in the trial will have T4 mixed with a radioactive substance called Indium 111. This substance is taken up by the T4 cells and makes them radioactive. This means that they show up on a special scan called a SPECT-CT scan. This allows the doctors to see where they go after injecting them into the tumour. The amount of radioactivity is small and you should have no side effects from it.
Hospital visits
You will see the doctors and have some tests before you have treatment. The tests may include
- A tissue sample (biopsy)
- Physical examination
- Blood tests
- Heart trace (ECG)
- Heart scan (Echocardiogram or MUGA)
- CT scan
- MRI scan
- PET-CT scan
- Chest X-ray
You have to stay in hospital for a week after having the T4 immunotherapy injection. Before discharge, you may have a SPECT-CT scan.
You see the doctors 3 days after you have the injection to have a blood test and possibly a SPECT-CT scan. 5 to 7 days after the injection you have another blood test and a heart scan. The following day you see the doctors and have blood tests and an ECG.
Around 2 weeks, 4 weeks and then 6 weeks after you have the injection you see the doctors and have more blood tests, an ECG, a heart scan and a chest X-ray.
If you had a sample of your cancer taken (a biopsy) before you had the injection then this might be done again when you see the doctors, either 2 weeks or 4 weeks after treatment.
If you had a PET-CT scan done before you started treatment then this will be repeated at your 6 week appointment.
You have a number of blood tests before, during and after your treatment. These are an important way for the doctors to monitor how the treatment is working and how your body reacts to the T4 immunotherapy.
In total you might be in the trial for up to 3 months. After you finish the trial your doctors will tell you how often they will see you.
Side effects
T4 immunotherapy is a new treatment and so not all side effects are known. The trial team is looking at all the side effects and you will have a telephone number to contact them if you are worried about anything.
So far T4 immunotherapy is proven to be safe in the people that have been treated. After treatment they have had a fever and the area of cancer that was injected had become swollen and inflammed. They had an anti inflammatory drug called celecoxib to help with this.
In other research studies using similar treatment side effects included
- High temperature (fever), chills, sweating, aches and pains and headache. Occasionally this may be severe.
- Feeling tired and lacking energy (fatigue)
- A change to the way organs such as the liver, heart, lungs or kidneys works (the doctors will test for this)
- Shortness of breath
We have information about the side effects of
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr John Maher
Supported by
Guy’s and St Thomas’ NHS Foundation Trust
King's College Hospital NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
