EPCORE™NHL-1: a phase 1/2 trial of GEN3013 in people with B-cell non-Hodgkin lymphoma that has come back or has not responded to treatment
A trial looking at the medication GEN3013 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
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.
Results have been published from the first 68 people who took part in the trial.
Trial aim and background
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) in patient with refractory or relapsed B-cell non-Hodgkin lymphoma.
All participants in the study have treatment with GEN3013 which is given as an injection under the skin.
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. This part of the trial has now closed.
- 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 ‘T-cell bispecific antibody’ (TCB) which attaches to targets on B cells and to a protein called CD3 on T cells. This brings the healthy T cells into close contact with the cancerous B cells, boosting the immune response to the cancer.
Who can enter
Adults with a B-cell lymphoma that makes a protein called CD20, and have previously been treated with rituximab or an autologous stem cell transplant may be eligible for this trial.
Locations
Recruitment is taking place in the following UK locations:
- The Christie NHS Foundation Trust, Manchester
- Derriford Hospital, Plymouth
- Royal Marsden NHS Foundation Trust, Sutton
Further information
More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: clinicaltrials.gov/ct2/show/NCT03625037
Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.