Purpose of trial
This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment but the trial will give important information about this new treatment, which could help other people in the future.
The aim of this trial is to find out more about using a new treatment called ADCT-402 to treat B-cell non-Hodgkin lymphoma that has relapsed (come back) or is refractory (not responding to treatment).
It aims to find out:
- the safest and most effective dose to use
- more about the side effects
- how well the treatment works
- how the treatment behaves in the body.
This trial is looking at a treatment called ADCT-402. This is made up of an antibody joined to a drug that should kill lymphoma cells. The antibody targets a protein found on the surface of many lymphoma cells, called CD19. The antibody carries the drug to the lymphoma cells wherever they are in the body.
You have the treatment intravenously (through a drip into your vein) once every three weeks. This trial is in two parts.
- Part 1 is to find out the highest safe dose of the treatment. This is done by dose escalation. Participants are treated in groups of 3. The first 3 participants have the lowest dose. The next 3 have a higher dose. This continues and everyone taking part is monitored closely for side effects. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
- Part 2 is to test how well the highest safe dose of the study treatment works. People entering this part of the trial all have the same dose of the study treatment.
How long you have the treatment for depends on how well it works and on the side effects you have. You can continue to have the treatment for as long as your lymphoma responds to it.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 175 people are needed for this trial.
You may be able to enter if:
- You have B-cell non-Hodgkin lymphoma that has come back or has not responded to treatment.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You agree to have a pregnancy test a week before starting treatment if there is any chance that you could be pregnant.
- Your blood and other health test results are satisfactory.
- You have previously had at least one course of treatment for your lymphoma.
- You are 18 or over.
You will not be able to enter if:
- There is any existing standard treatment available for your lymphoma that you haven’t already had.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You still have significant side effects from your previous treatment.
- You have a complication of previous treatment called ‘ graft versus host disease ’.
- You have had a stem cell transplant within the last 60 days.
- You have had any autoimmune disease or conditions called Steven’s Johnson’s syndrome or toxic epidermal necrolysis syndrome in the past.
- You’ve had major surgery, radiotherapy or other cancer treatment (including other trial treatments) within 2 weeks of starting treatment in this trial.
- You are taking steroids within four weeks of starting treatment in this trial.
- You have another type of cancer, except certain localised cancers.
- You have HIV, hepatitis C virus or hepatitis B virus.
- You are pregnant or breastfeeding.
- Any of the study drugs are not suitable for you.