Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
85
Countries
3
Sites
10
Relapsed/refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL)
Key facts
- Sponsor
- Byondis B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 9 Jun 2023 → ongoing
- Decision date (initial)
- 2024-07-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512390-27-00
- EudraCT number
- 2022-002018-18
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Byondis B.V.
- Sponsor organisation
- Byondis B.V.
- Address
- Microweg 22
- City
- Nijmegen
- Postcode
- 6545 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 26 | 5 |
| Netherlands | Ongoing, recruitment ended | 16 | 2 |
| Spain | Ended | 24 | 3 |
| Rest of world
United Kingdom
|
— | 19 | — |
Investigational sites
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Ematologia Clinica, Piazzale Spedali Civili 1, 25123, Brescia
Istituto Europeo Di Oncologia S.r.l.
Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Unita Sanitaria Locale Della Romagna
Ematologia, Viale Vincenzo Randi 5, 48121, Ravenna
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncoematologia, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Ospedale San Raffaele S.r.l.
Unità di Ematologia e Trapianto di Midollo Osseo, Via Olgettina 60, 20132, Milan
Stichting Amsterdam UMC
Department of Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Radboud universitair medisch centrum / RADBOUDUMC
Department of Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2023-12-08 | 2025-10-30 | 2024-02-20 | 2025-10-03 | |
| Netherlands | 2023-06-09 | 2024-11-11 | 2025-10-03 | ||
| Spain | 2023-06-28 | 2025-11-18 | 2024-04-17 | 2025-10-03 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Spain | Acceptable 2024-07-03
|
2024-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-29 | Spain | Acceptable 2024-10-21
|
2024-10-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Spain | Acceptable | 2025-03-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-28 | Spain | Acceptable | 2025-04-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-08 | Spain | Acceptable | 2026-04-08 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-08 | Acceptable | 2026-04-08 |