Purpose of trial
The aims of the trial are:
- to find the best dose of BI-1206 alone and in combination with rituximab for treating B-cell lymphoma
- to find out how effective BI-1206 is alone and combined with rituximab
- to find out the possible side effects of these treatments
- to look at how the drug moves through the body (pharmacokinetics).
BI-1206 is an antibody that binds (sticks) to a protein called CD32b, which is found on some B-cell lymphoma cells. It can attract other immune system cells to destroy the cancer cells. It might also enhance the anti-cancer effect of other antibody treatments like rituximab.
There are 2 parts to this trial.
- Part 1 is to find the best dose of BI-1206. 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 the participants are 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 best dose of BI-1206 from part 1 works alone or in combination with rituximab.
There are 2 groups in Part 2:
- Group A receive the recommended dose of BI-1206 from Part 1. Up to 25 people can be included in this group.
- Group B receive BI-1206 with rituximab. Different doses of the 2 drugs are given using a dose escalation scheme to make sure they are safe to use in combination. The highest safe dose is then tested in up to 25 people.
You might enter the trial at part 1 or part 2. You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.
Both BI-1206 and rituximab are given intravenously (through a drip into a vein).
You have BI-1206 once a week for 4 weeks. If you are also having rituximab, you have rituximab alone for 1 week before starting BI-1206. You then have both rituximab and BI-1206 once a week for the next 4 weeks. BI-1206 is given first, followed by rituximab. The drugs are given on 2 separate days the first time they are given but may be given on the same day for the next treatments.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 81 people are needed for this trial.
You may be able to enter if:
- You have CLL or another B-cell lymphoma that has relapsed (come back) or didn’t respond well to treatment (refractory lymphoma).
- Your lymphoma is CD32b positive. It must also be CD20 positive if you are in the rituximab group. Your doctor can advise you if this applies to you.
- Your lymphoma is measurable with the tests used in the trial.
- You have had at least 1 previous course of treatment with a regimen (combination of drugs) that included rituximab.
- You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work.
- Your blood and other health test results are satisfactory.
- You are willing to use reliable contraception for 4 weeks before trial treatment, during the trial and for at least a year after completing the trial treatment.
- You are 18 or over.
You will not be able to enter if:
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- Your lymphoma has transformed (changed) from a low-grade lymphoma to a high-grade lymphoma.
- You’ve had an allogeneic stem cell transplant in the past 12 months or you have chronic graft versus host disease.
- You are taking steroids unless at a low dose (your doctor can advise you if this applies to you).
- You have certain other conditions including types of amyloidosis, heart conditions, autoimmune conditions, systemic diseases (affecting the whole body) or infections that might make it unsafe for you to take part.
- You have hepatitis B, hepatitis C or HIV.
- You are not suitable for the study drugs, eg because of an allergy to any of the ingredients.
- You are taking part in a clinical trial of another experimental drug.
- You’ve had another anti-cancer treatment in the 4 weeks before starting the trial treatment.
- You still have side effects from previous treatments unless they are mild and the trial team agree that they won’t affect your safety in the trial.
- You are pregnant or breastfeeding.
- You’ve had major surgery that you have not yet recovered from.
- You have had another cancer in the last 3 years except certain localised cancers.