Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
210
Countries
2
Sites
8
mature B-Cell malignancies
Key facts
- Sponsor
- Beigene Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 19 Dec 2025
- Decision date (initial)
- 2025-09-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521600-21-00
- ClinicalTrials.gov
- NCT05828589
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
mature B-Cell malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Beigene Ltd.
- Sponsor organisation
- Beigene Ltd.
- Address
- Solaris Avenue 94
- City
- Camana Bay
- Postcode
- KY1-1108
- Country
- Cayman Islands
Scientific contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeiGene Clinical Support
Public contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeiGene Clinical Support
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 9 | 4 |
| Italy | Ended | 9 | 4 |
| Rest of world
Australia, United States, China, New Zealand
|
— | 192 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Département d'Hématologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Oncopole Claudius Regaud
Département d'Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Dijon
Département d'Hématologie, 14 Rue Paul Gaffarel, 21000, Dijon
Hopital Saint Louis
Département d'Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Humanitas Mirasole S.p.A.
Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano
Centro Ricerche Cliniche Di Verona S.r.l.
Hematology unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Ematologia, Via Mariano Semmola 52, 80131, Naples
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-11 | Italy | Acceptable 2025-09-29
|
2025-09-29 |