The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Official Title: 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)
Study ID: NCT05737628
Brief Summary: This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
Detailed Description: This study includes a dose escalation part (Part 1) in which the MTD and dose regimen for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts. BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
ASST Spedali Civili di Brescia, Brescia, , Italy
Amsterdam Universitair Medisch Centrum locatie VUmc, Amsterdam, , Netherlands
Radboud UMC, Nijmegen, , Netherlands
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Català d'Oncologia, Barcelona, , Spain
Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro, Madrid, , Spain
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Name: Willem Klaassen
Affiliation: Byondis B.V., The Netherlands
Role: STUDY_DIRECTOR