Athena-1
Research type
Research Study
Full title
A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)
IRAS ID
1006784
Contact name
Hsiao-Chi Lo
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2020-005084-32
Research summary
This Phase 1, open label study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab in patients with relapsed or refractory aggressive B-Cell Non Hodgkin Lymphomas (B-NHLs). The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose. The study is looking at several other research questions, including:
• What side effects may happen from taking the study drugs
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
• Exploratory research to better understand the study drugs and B-NHLs (and other types of cancers)In order to do this, potential participants will enter into a screening period lasting up to 28 days. Following the screening period, participants will enter into the odronextamab monotherapy period. The monotherapy period will see participants receive only one of the study drugs (odronextamab) and not both study drugs (odronextamab and REGN5837). Depending on how well participants tolerate odronextamab, their dose will be escalated during this period. If no major side effects are experienced, participants will then begin treatment with REGN5837 in combination with odronextamab. The dosing will be increased dependant on participant response to the combined treatment. Participants will receive a total of 12 combined doses of odronextamab and REGN5837.
Once treatment is completed, participants will return to clinic for safety tests every 4 weeks, for 12 weeks. Participants may continue to see the study doctor after this, in which case the study team will continue to collect information about the participants health status every 12 weeks. Otherwise they will be contacted via telephone by the study team for this data.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0419
Date of REC Opinion
9 Feb 2023
REC opinion
Further Information Favourable Opinion