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BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every four weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

Rituximab IV infusion (375 mg/m2) starts after first BYON4228 cycle. Weekly infusion during the first cycle and every four weeks in subsequent 5 cycles.

20 mg/mL BYON4228 in 8 mL solution for infusion.

Rituximab 500 mg concentrate for solution for infusion.

BYON4228 + Rituximab

Willem Klaassen

Dr. A. Re

Dr. M. Chamuleau

Dr. W. Stevens

Dr. F. Bosch Albareda

Dr. E. Gonzalez Barca

Dr. J. Perez De Oteyza

Dr. K. Linton

Dr. D. Lewis

This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.

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.

First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228

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)

Byondis B.V.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228	NCT05737628	Lymphoma	BYON4228 + Ritu...	18 Years -	Byondis B.V.
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228	NCT05737628	Lymphoma	BYON4228 + Ritu...	18 Years -	Byondis B.V.

Spots Global Cancer Trial Database for byon4228 + rituximab