Clinical trial • Phase I • Oncology|Haematology

BYON4228 (SIRPα-directed monoclonal antibody) for Relapsed/refractory CD20-positive B-cell Non-Hodgkin lymphoma

Phase I trial of BYON4228 (SIRPα-directed monoclonal antibody) for Relapsed/refractory CD20-positive B-cell Non-Hodgkin lymphoma. 66 participants.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Relapsed/refractory CD20-positive B-cell Non-Hodgkin lymphoma
Trial Stage
Phase I
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
24-05-2024
First CTIS Authorization Date
03-07-2024

Trial design

Phase I trial across 10 sites in Netherlands, Spain, Italy.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
66

Eligibility

Recruits 66 Vulnerable population selected; no further details on the nature of vulnerability, consent or assent handling are provided in the record..

Vulnerable Population
Vulnerable population selected; no further details on the nature of vulnerability, consent or assent handling are provided in the record.

Recruitment

Planned Sample Size
66
Recruitment Window Months
38
Consent Approach
Vulnerable population selected; no information on the informed consent or assent process (who provides consent, age-specific documents, or languages available) is provided in the record.

Geography

Total Number Of Sites
10
Total Number Of Participants
66

Netherlands

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
142
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Department of Hematology
Contact Person Name
Wendy Stevens
Contact Person Email
wendy.stevens@radboudumc.nl
Site Name
Stichting Amsterdam UMC
Department Name
Department of Hematology
Contact Person Name
Martine Chamuleau
Contact Person Email
m.chamuleau@vumc.nl

Spain

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
296
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
Francesc Bosch Abareda
Contact Person Email
fboch@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Eva María Gonzalez Barca
Contact Person Email
e.gonzalez@inconcologia.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Hematology
Contact Person Name
Damian Cubillas García de la Torre

Italy

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
673
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Ematologia e Trapianto di Midollo Osseo
Contact Person Name
Andres Ferreri
Contact Person Email
Ferreri.andres@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncoematologia
Contact Person Name
Enrico Derenzini
Contact Person Email
Enrico.Derenzini@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Ematologia Clinica
Contact Person Name
Chiara Pagani
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ematologia
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncoematologia
Contact Person Name
Umberto Vitolo
Contact Person Email
umberto.vitolo@ircc.it

Sponsor

Primary sponsor

Full Name
Byondis B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
BYON4228
Active Substance
BYON4228 (SIRPα-directed monoclonal antibody)
Modality
Monoclonal antibody
First In Human
Yes
Investigational Product Name
Rituximab
Active Substance
Rituximab
Modality
Monoclonal antibody
Combination Treatment
Yes

Related trials

Other published trials that may interest you.