This is a
phase 1/2 study. The researchers need 80 people to join. Everyone who is able to will have AUTO2 treatment.
The 2 parts of the study
There are 2 parts to this study. Your doctor will tell you which part you are in when you agree to take part.
Part 1 is a dose escalation study. This is to find the best safe dose of AUTO2 to give. The researchers are looking at 5 doses.
The first few people will have the lowest dose. If they don’t have any bad side effects the next few people will have the next dose. If they don’t have any bad side effects the next few will have the highest dose.
Part 2 is a dose expansion study. The researchers use the best safe dose of AUTO2 from part 1.
About the AUTO2 treatment
The AUTO2 treatment is made in the manufacturing unit using a particular type of white blood cell called T cells. These are your own T cells that they collect (remove) from your blood during a process called leukapheresis.
Leukapheresis
They take the blood from your vein and put it through a machine. The machine separates the T cells from the blood. They remove the T cells and give the rest of your blood back into your bloodstream. You have this up to 3 months before the AUTO2 treatment.
Your chemotherapy and AUTO2 treatment might be delayed if any of the following happen after the leukapheresis:
- you have a severe infection when you are due to have treatment
- you need to have oxygen
- you have pus, blood or similar substances in your lungs when you are due to have treatment
- your liver or kidneys aren’t working well enough
Chemotherapy
You go in to hospital to have low dose chemotherapy. The chemotherapy helps the AUTO2 treatment survive and grow in your body.
The chemotherapy drugs you have are cyclophosphamide and fludarabine. You have both drugs as a
drip into your bloodstream. Each one takes about 30 minutes to have. You have them once a day for 3 days before having the AUTO2 treatment.
AUTO2
You have the AUTO2 treatment between 3 and 5 days after the chemotherapy. You have it as drip into a vein within 30 minutes. You usually have it as a single dose.
Sometimes they can't make the AUTO2 treatment because there weren’t enough white blood cells.
Your doctor will talk to you about what other treatments are available if this happens.
