*ELM-1
Research type
Research Study
Full title
An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-Directed Antibody Therapy
IRAS ID
1004432
Contact name
Laura Simpson
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2015-004491-30
Clinicaltrials.gov Identifier
Research summary
This Phase I study involves the use of an experimental drug called REGN1979 (odronextamab).
Odronextamab is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is made as a medication to go after specific proteins in the body that may be involved in your cancer.
The main purpose of this study is to:
• Learn about the safety of the study drug and to find out what dose of the study drug can be given to patients with B-cell NHL without too many side effects.
The study will also:
• Look at the levels of odronextamab in your blood and evaluate the change of drug concentrations over time following dosing (called pharmacokinetics).
• Look at any signs that odronextamab can fight your cancer.
This study will enrol up to 298 patients at approximately 40 sites globally. Patients with Non-Hodgkin’s lymphoma (referred to as NHL) may be eligible to participate.
This is a 2- part study. In part A, odronextamab is studied as an intravenous (IV) administration, where odronextamab is given through a vein (IV infusion) or a central line if the patient has one. In Part B, odronextamab is studied as subcutaneous administration (SC), where odronextamab doses are given under the skin (SC injection). The type of odronextamab, and the schedule participants follow will depend on which part of the study they are assigned. Assignment is based on what subtype of NHL you are diagnosed with.
During the study participants will undergo study related tests and procedures such as physical examinations, blood and urine samples, electrocardiograms and tumour assessments.
This study is being sponsored by Regeneron Pharmaceuticals, Inc.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/FT/0017
Date of REC Opinion
25 Apr 2022
REC opinion
Further Information Favourable Opinion