Clinical Research Directory
Browse clinical research sites, groups, and studies.
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Sponsor: Byondis B.V.
Summary
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2024-03-04
Completion Date
2026-05
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
BYON4228 + Rituximab
BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every four weeks until disease progression or unacceptable toxicity. Different doses. Rituximab IV infusion (375 mg/m2) starting from the second treatment cycle onwards. Weekly infusion during the first cycle and every four weeks in subsequent 5 cycles.
Locations (12)
ASST Spedali Civili di Brescia
Brescia, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Italy
Instituto Europeo di Oncologia
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST
Ravenna, Italy
Vrije Universiteit Medisch Centrum
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
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom