Last updated on February 2018

BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia

Brief description of study

The purpose of this study is to identify the tolerable dose of BI-1206 for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody

Detailed Study Description

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 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.

Clinical Study Identifier: NCT02933320

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Recruitment Status: Open

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