- dose escalation (part 1)
- dose expansion (part 2)
In part 1 doctors are looking for the best dose of AUTO4. They hope that around 25 people will agree to take part.
Part 2 starts when doctors find the best dose of AUTO4. They give the best dose found in part 1 to more people. Doctors hope that up to 30 people will join the second part of this trial.
Please note – doctors are currently looking for people to join the 1st part of this trial.
There are 4 steps in this trial:
- biopsy
- collection of white blood cells (leukapheresis)
- chemotherapy
- having the changed white blood cells back (AUTO4 treatment)
Biopsy
Your doctor asks to use a sample of your cancer taken when you had a biopsy. You might need to have a new sample taken if there isn't a suitable sample available. Doctors want to check whether there are TRBC1 proteins on the surface of the lymphoma cells.
Your doctor will tell you more about having a biopsy. How you have this depends on your individual situation.
If your lymphoma does not have TRBC1 proteins on its surface (TRBC1 negative), you can’t continue taking part in the trial. Your doctor will tell you about other treatments that you may be able to have.
You continue this trial if your lymphoma has TRBC1 proteins on its surface (TRBC1 positive). You have more tests such as blood tests and a CT scan to check that you meet all the other entry conditions of this trial.
Collection of white blood cells (leukapheresis)
Leukapheresis is a procedure to collect white blood cells from your bloodstream.
You lie on a bed or reclining chair and have a tube into a vein in your arm. The tube takes the blood and puts it through a machine that separates the T cells (white blood cells) from the blood. The rest of your blood goes back to your body.
Researchers in the laboratory modify and grow your T cells to recognise and attack the lymphoma cells. It usually takes between 4 to 6 weeks to do this.
It isn’t always possible to collect enough T cells during leukapheresis. You may have this procedure twice if this happens.
Sometimes, researchers can’t grow enough T cells in the laboratory. Your doctor will talk to you about other treatment that you might be able to have if this happens.
Chemotherapy
A week before you have the AUTO4 treatment, you have chemotherapy. This helps the changed T cells to survive and grow inside the body:
The chemotherapy treatment you have includes:
Having the changed white blood cells back (AUTO4 treatment)
You have the changed T cells back as a drip into your vein. It takes about 30 minutes to have it. The trial team can tell you if this applies to you.
You need to stay in hospital after having the AUTO4 treatment. This is so doctors can monitor you for any side effects. They will tell you how many days you need to stay in hospital for. This is usually at least 2 weeks.