Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT02933320
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2016-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
Sponsor:
Cancer Research UK
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-004999-29 | EUDRACT_NUMBER | None | View |