A trial looking at T4 immunotherapy for people with head and neck cancer

Cancer type:

Head and neck cancers

Status:

Open

Phase:

Phase 1

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 Open a glossary item. And the cancer either needs to be locally advanced Open a glossary item 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 Open a glossary item. Some people in the trial will also have a low dose of the chemotherapy drug cyclophosphamide. You take this as tablets.

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 Open a glossary item 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 Open a glossary item
  • 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
  • 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 Open a glossary item (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 Open a glossary item 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 Open a glossary item removed (a splenectomy)
  • You have an autoimmune disease Open a glossary item
  • 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

Depending on when you join the trial you will also not be able to take part if you are allergic to cyclophosphamide. Your doctors can advise you about this.

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 take the chemotherapy drug cyclophosphamide.

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 uses an ultrasound scan to guide the injection. They inject it into a number of areas of the cancer.

If you are in the group having cyclophosphamide you have this as a tablet. You take it once a day for 2 weeks before you are due to have the T4 immunotherapy injection.

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

You have to stay in hospital overnight on the day you have the T4 immunotherapy injection. Before discharge on day 2, 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.

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 cyclophosphamide

Location

London

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr John Maher

Supported by

Guy’s and St Thomas’ NHS Foundation Trust
King's College Hospital NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12169

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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