A Phase I trial of DI-B4 in patients with advanced B-cell malignancies
Research type
Research Study
Full title
A Cancer Research UK Phase I trial of the Anti-CD19 DI-B4 monoclonal antibody given intravenously, weekly for four weeks in patients with advanced CD19 positive indolent B-cell malignancies.
IRAS ID
119393
Contact name
Andrew Davies
Sponsor organisation
Cancer Research UK
Eudract number
2012-002133-11
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The proposed study is a first in man study to determine the maximum tolerated dose (to a maximum dose of 1000mg) of the drug called DI-B4. The molecule CD19 is present on all B-cells including the malignant B-cells in non-Hodgkin Lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and acute lymphoblastic leukaemia (ALL). The study drug, DI-B4, is an anti-CD19 monoclonal antibody which attaches to CD19 on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death. We wish to find out if it will be useful in treating patients with certain types of lymphoma. The three main aims of this clinical study are to find out: - The maximum dose of DI-B4 that can be given safely to patients (to a maximum dose of 1000mg). - More about the potential side effects of DI-B4 and how they can be managed. - What happens to DI-B4 inside the body. Approximately 35-40 patients with relapsed or refractory CD19 positive indolent B-cell lymphoma or chronic lymphocytic leukaemia will be entered into this study. This will include approximately 15-20 recruited for the dose escalation phase, and up to a further 20 patients recruited to a dose expansion cohort. The final number will depend on the number of dose escalations required to reach the maximum tolerated dose or the maximum administered dose of 1000mg.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
13/SC/0003
Date of REC Opinion
30 Jan 2013
REC opinion
Favourable Opinion