BI-1206-01 trial

Chief investigator - Dr Andrew Davies, University of Southampton
Amount awarded: Not specified
Award start date: 01 Nov 2014
Recruitment start date: 04 Oct 2016
Award duration: 5 years (60 months)

Researchers have developed a drug called BI 1206, which is a type of biological therapy called an antibody. It works by recognising and attaching to a particular protein called CD32b found on the surface of some types of lymphoma and leukaemia cells.

Studies show that when BI 1206 blocks the CD32b protein on cancer cells in the laboratory, it prevents the cancer cells from growing and dividing. 

It might also enhance the anti-cancer effects of other antibody treatments, such as rituximab, which is used in the treatment of non-Hodgkin lymphoma and CLL. Rituximab works by blocking a protein called CD20, which found on the surface of some types of lymphoma and leukaemia cells. But unfortunately, some people can become resistant to rituximab. BI 1206 is thought to help prevent resistance by maintaining the CD20 protein on the cancer cells.

Researchers now want to find out if BI 1206 can help people with B cell non Hodgkin lymphoma and chronic lymphocytic leukaemia (CLL). This will be the first time the drug is given to people.

The trial will be in two parts. 

The first part aims to find the highest safe dose of BI 1206 to give. Once this is established, the dose will be used in the second part. 

In the second part of the trial, participants will receive either: 

• BI 1206 alone

• BI 1206 and rituximab

The aims of the second part will be to find the highest safe dose of BI 1206 to give with rituximab.

You may be eligible to join this trial if:

• You have CLL or another B-cell lymphoma that has relapsed, or didn’t respond to treatment

• Your lymphoma is CD32b positive, and it must be CD20 positive if you are in the rituximab group

• You are 18 or over

Other eligibility criteria apply.