The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed. The study will also look at what happens to Anti-CD19 (DI-B4) inside the body.
DI-B4 is a type of drug called an Anti-CD19 monoclonal antibody which is being used to stop the growth and kill cancerous immune cells by targeting the B-cell marker (CD-19) expressed on their surface. This drug has not been given to patients before.
DI-B4 is a humanised, low-fucosylated anti-CD19 Immunoglobulin (Ig) G1 monoclonal antibody with potent antibody-dependent cell-mediated cytotoxicity (ADCC) but minimal complement dependent cytotoxicity (CDC). The target antigen, CD19, is the canonical B-cell marker that is expressed on all B-cells including the malignant B-cells in NHL, CLL and acute lymphoblastic leukaemia (ALL). The CD19 antigen is therefore an attractive B-cell lineage specific target for monoclonal antibody therapy. DI-B4 is expected to act through the depletion of normal and malignant CD19 positive cells, primarily via ADCC.
Royal Liverpool and Broadgreen University Hospital NHS TrustNot yet recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Contact Person A.R.Pettitt@liverpool.ac.uk
Principal Investigator: Andrew Petitt, Dr
The Royal London HospitalNot yet recruiting
London, United Kingdom, E1 1BB
Contact: Contact Person firstname.lastname@example.org
Principal Investigator: John Gribben, Dr
The Christie NHS Foundation TrustNot yet recruiting
Manchester, United Kingdom, M20 4BX
Contact: Contact Person John.Radford@manchester.ac.uk
Principal Investigator: John Radford, Dr
University Hospital Southampton NHS Foundation TrustNot yet recruiting
Southampton, United Kingdom, S016 6YD
Contact: Andrew Davies, Dr 023 8079 6184 A.Davies@soton.ac.uk
Principal Investigator: Andrew Davies, Dr