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ACTIVE NOT RECRUITING
NCT05737628
PHASE1

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

Sponsor: Byondis B.V.

View on ClinicalTrials.gov

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

DRUG

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