Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
437
Countries
2
Sites
14
Mature B Cell Malignancies
Key facts
- Sponsor
- BeOne Medicines AG
- 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
- 14 Jun 2021 → ongoing
- Decision date (initial)
- 2024-10-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515592-35-00
- EudraCT number
- 2020-004641-37
- WHO UTN
- U1111-1309-4593
- ClinicalTrials.gov
- NCT04277637
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 | HLT | 10029592 | Non-Hodgkin's lymphomas NEC | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- Beigene Ltd.
- Contact name
- BeOne Medical Officer
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 34 | 6 |
| Spain | Ongoing, recruitment ended | 35 | 8 |
| Rest of world
Australia, New Zealand, United Kingdom, United States
|
— | 368 | — |
Investigational sites
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Ematologia, Oncologia e Medicina Molecolare, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Ematologia e Trapianto di cellule staminali emopoietiche, Largo Francesco Vito 1, 00168, Rome
Hospital Santa Maria Della Misericordia
S.C. Ematologia e Trapianto, Piazzale Giorgio Menghini 1, 06129, Perugia
Ospedale San Raffaele S.r.l.
U.O. Ematologia e Trapianto di Midollo Osseo, Via Olgettina 60, 20132, Milan
Azienda Unita Sanitaria Locale Della Romagna
U.O. di Ematologia, Viale Vincenzo Randi 5, 48121, Ravenna
Centro Ricerche Cliniche Di Verona S.r.l.
U.O.C Ematologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Hospital De La Santa Creu I Sant Pau
Hematology Department, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
Hematology unit, Avenida Valdecilla Sn, 39008, Santander
Vall D Hebron Institute Of Oncology
Department of Hematology, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Hematology department, Pio XII Etorbidea 36, 31008, Pamplona
Institut Catala D'oncologia
Hematology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Hematology Department, Calle Villarroel 170, 08036, Barcelona
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 | 2021-10-21 | 2022-04-07 | 2025-01-07 | ||
| Spain | 2021-06-14 | 2021-09-10 | 2025-01-07 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Spain | Acceptable 2024-10-10
|
2024-10-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-15 | Spain | Acceptable with conditions 2025-04-01
|
2025-04-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-08 | Spain | Acceptable 2025-07-14
|
2025-07-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-14 | Spain | Acceptable 2025-08-20
|
2025-08-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-19 | Spain | Acceptable 2026-02-10
|
2026-02-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-19 | Spain | Acceptable 2026-05-18
|
2026-05-19 |