BI-1206 + anti-CD20 in patients with CD32b positive B-cell malignancy
Research type
Research Study
Full title
A Cancer Research UK Phase I/IIa clinical trial of BI-1206; an antibody to FcƔRIIB (CD32b), as a single agent and in combination with an anti-CD20 antibody in patients with CD32b positive B-cell malignancy.
IRAS ID
201430
Contact name
Julie Silvester
Contact email
Sponsor organisation
Cancer Research UK, Centre for Drug Development
Eudract number
2015-004999-29
Duration of Study in the UK
5 years, 3 months, 28 days
Research summary
The molecule CD32b is thought to be present on many B-cells including the malignant B-cells in some types of lymphoma and leukaemia. The study drug, BI-1206, is an anti-CD32b monoclonal antibody which attaches to CD32b on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death as well as enhancing the anti-cancer effect of other anti-CD20 antibodies such as rituximab by stopping them being absorbed by cells.
The proposed study is a first in man clinical trial of the drug called BI-1206 on its own and then also in combination with an anti-CD20 antibody (such as rituximab) which is commonly used to treat lymphoma and some types of leukaemia.
The four main aims of this trial are to find out:
- The maximum dose of BI-1206 that can be given safely to patients (to a maximum dose of 800mg) on it's own and in combination with an anti-CD20 antibody, rituximab.
- More about the potential side effects of BI-1206 and how they can be managed.
- What happens to BI-1206 inside the body.
- The effect of BI-1206 treatment (with or without rituximab) on tumour size and survival.
Approximately 81 patients with relapsed or refractory CD32b positive B-cell lymphoma or leukaemia will be entered into this study. This will include approximately 19 recruited for the BI-1206 dose escalation phase (Part A), up to 12 (likely 6) for a combination dose escalation and up to a further 50 patients recruited to two dose expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number will depend on the number of dose escalations required to reach the MTD.REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0853
Date of REC Opinion
20 Jun 2016
REC opinion
Further Information Favourable Opinion