NCT02933320

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 were planned for the trial. Approximately 34 patients to establish the maximum tolerated doses (MTDs) in Part A and a further 40 to 50 patients recruited to two expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number depending on the number of dose escalations required to reach the MTD.

Conditions

• B-cell Lymphoma
• Chronic Lymphocytic Leukaemia
• Waldenström Macroglobulinemia

Interventions

Type	Name	Description
BIOLOGICAL	BI-1206 single agent dose escalation phase	BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.
BIOLOGICAL	Combination of BI-1206 with rituximab escalation phase	An investigation of combination treatment of BI-1206 with rituximab.
BIOLOGICAL	BI-1206 single agent expansion phase	BI-1206 single agent expansion phase at the RP2D.
BIOLOGICAL	Combination of BI-1206 with rituximab expansion phase	BI-1206 in combination with rituximab at the RP2D.

Timeline

• Start date: 2016-10-27
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2016-10-14
• Last updated: 2021-07-08
• Results posted: 2021-07-08

Locations

5 sites across 1 country: United Kingdom