Purpose of trial
The aim of this trial is to establish the safety and work out the best dose of a new treatment called GEN3013 (also called DuoBody®-CD3xCD20). It is for people with B-cell non-Hodgkin lymphoma that is getting worse (progressing), has come back (relapsed) or has not responded (refractory) to other treatment.
All participants in the study have treatment with GEN3013.
This trial is in two parts:
- Part 1 is to find out the highest safe dose of GEN3013. This is done by ‘dose escalation’. Different participants are treated with different doses of GEN3013. 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 GEN3013 works. People entering this part of the trial all have the same dose of GEN3013.
GEN3013 is a type of antibody called a ‘T-cell bispecific antibody’ (TCB). Most antibody treatments attach to one target protein but TCBs can attach to two targets on different cells (they are ‘bispecific’). GEN3013 attaches to a protein called CD20 on B cells and to a protein called CD3 on T cells. This brings your healthy T cells into close contact with the cancerous B cells, boosting your immune response to the cancer.
You have GEN3013 as an injection under the skin (a subcutaneous injection). You have the treatment in cycles. Each cycle is 28 days.
- In cycles 1 and 2 you have one injection of GEN3013 once a week.
- In cycle 3 to 6, you have one injection of GEN3013 every second week.
- In cycle 7 onwards, you have one injection of GEN3013 every 4 weeks.
You carry on having the treatment until your lymphoma gets worse or unless you have troublesome side effects.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 110 people are needed for this trial but only a few of these are in the UK.
You may be able to enter if:
- You have a type of B-cell lymphoma that makes a protein called CD20. Your doctor can tell you if this is the case.
- You have previously had treatment with rituximab or another antibody therapy that targets CD20 (either on its own or with chemotherapy) or an autologous stem cell transplant (using your own stem cells).
- Your lymphoma can be measured by the tests used in the trial.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You won’t be able to enter if:
- You have heart disease that might make it unsafe for you to have the trial treatment.
- You have lymphoma affecting your central nervous system (CNS; brain and spinal cord).
- Your doctor thinks you could respond to salvage therapy followed by a stem cell transplant.
- You have an active or uncontrolled infection.
- You have HIV, hepatitis C or hepatitis B.
- You had any live vaccines in the 4 weeks before the trial.
- You are pregnant or breastfeeding.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03625037