Safety and efficacy of a new medicinal drug BYON4228 in patients with non-Hodgkin lymphoma
Research type
Research Study
Full title
A first-in-human dose escalation and expansion study with the SIRPα-directed monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL)
IRAS ID
1006834
Contact name
Evelyn Van den Tweel
Contact email
Sponsor organisation
Byondis BV
Eudract number
2022-002018-18
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the safety and activity of a new medicinal drug called BYON4228 in patients with Non-Hodgkin's Lymphoma. It is the first time that BYON4228 will be administered to humans. BYON4228 binds to a specific protein on immune cells and as a result it may improve the immune system and other drugs to attack the cancer. The safety and activity of BYON4228 will be evaluated when given alone and when given in combination with rituximab. Rituximab is an approved drug used to treat different kinds of cancers. In the first part of the study, the best dose of BYON4228 will be determined and in the second part of the study more patients will be treated with that dose.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0213
Date of REC Opinion
20 Feb 2023
REC opinion
Further Information Favourable Opinion