This is a
phase 1/2 trial. It is taking place in the United Kingdom. There are 2 parts to the trial, part 1 and part 2.
In part 1 researchers are looking at the best dose of CAR T-cells to have. The researchers hope around 50 people will take part. Phase 1 is open for people to take part.
In part 2 they are testing this dose in more people. Part 2 will begin when they find the best dose in part 1. The researchers hope around 101 people will take part in Part 2.
There are 4 steps to your treatment:
- collecting your white blood cells (leukapheresis)
- a short course of chemotherapy
- having the T cells back
- pembrolizumab
Collecting 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. One tube removes blood and passes it into a machine that removes white blood cells. The rest of your blood goes back into your body through a
central line 
.
The researchers will then use gene therapy to change (modify) these cells in a laboratory. This is to make them able to recognise and attack lymphoma cells.
It isn’t always possible to grow enough cells. Your doctor will talk to you about this and about what other treatments that might be available if this happens.
A short course of chemotherapy
A week before you have CAR T-cell treatment, you have chemotherapy. This helps the changed T cells to survive and grow inside the body.
You have 2 drugs called:
- cyclophosphamide
- fludarabine
You have them as a
drip into a vein. You have this once a day, for 3 days in a row in the week before having your T cells back. This takes about an hour each time.
Having the T cells back
You have the changed T cells back as a drip into a vein. It takes about 30 minutes. Some people might have this as 2 separate doses. The trial team can tell you more if this applies to you.
Pembrolizumab
Some people have a dose of pembrolizumab when they have their chemotherapy. And some people have it after having the T cells back. You have 3 doses of pembrolizumab. You have it once every 3 weeks as a drip into a vein.
The first 3 to 6 in the trial people won’t have this treatment.