Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
730
Countries
5
Sites
33
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] - Neoplasms [C04]
- Trial duration
- 18 Sep 2023 → ongoing
- Decision date (initial)
- 2023-07-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502157-33-00
- ClinicalTrials.gov
- NCT05006716
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
B-Cell Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 21.0 | PT | 10047801 | Waldenstrom's macroglobulinaemia | 100000004864 |
| 20.0 | PT | 10076596 | Marginal zone lymphoma | 100000004864 |
| 20.0 | PT | 10061275 | Mantle cell lymphoma | 100000004864 |
| 20.0 | PT | 10058728 | Richter's syndrome | 100000004864 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 21.1 | LLT | 10067070 | Follicular B-cell non-Hodgkin's lymphoma | 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
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Locations
5 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 75 | 9 |
| Germany | Ongoing, recruiting | 37 | 7 |
| Italy | Ongoing, recruiting | 90 | 6 |
| Spain | Ongoing, recruiting | 25 | 8 |
| Sweden | Ongoing, recruiting | 12 | 3 |
| Rest of world
China, Moldova, Republic of, Japan, Turkey, Canada, New Zealand, Brazil, United Kingdom, Korea, Republic of, Australia, Georgia, United States
|
— | 491 | — |
Investigational sites
University Hospital Of Clermont-Ferrand
Service hématologie, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Institut Bergonie
Service hématologie, 229 Cours De L Argonne, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Service hématologie clinique, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Assistance Publique Hopitaux De Paris
Unité Hémopathies Lymphoides, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Institut Paoli-Calmettes
Service hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Montpellier
Service hématologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Henri Becquerel
Département d'Hématologie, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Universitaire De Lille
Service Maladie du sang, Rue Michel Polonovski, 59037, Lille Cedex
Centre Leon Berard
Service hématologie, 28 Rue Laennec, 69008, Lyon
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Schleswig-Holstein
Klinik für Hämatologie, Onkologie, Ratzeburger Allee 160, 23538, Lübeck
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Medizinische Klinik und Poliklinik III, Hämatologie und Medizinische Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
UCC/NCT Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Ulm AöR
Klinik III für Innere Medizin, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaet Leipzig
Universitäres Krebszentrum Leipzig, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Centro Ricerche Cliniche Di Verona S.r.l.
Sezione di Ematologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
European Institute Of Oncology S.r.l.
UO Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Ospedale San Raffaele S.r.l.
Programma di ricerca strategica sulla LLC, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC ematologia, Largo Francesco Vito 1, 00168, Rome
ASST Grande Ospedale Metropolitano Niguarda
S.C. Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Hospital De La Santa Creu I Sant Pau
Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Hematolgy, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Hematology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario La Paz
Hematology, Paseo Castellana 261, 28046, Madrid
MD Anderson Cancer Center
Hematology, Calle De Arturo Soria Nº 270, 28033, Madrid
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 |
|---|---|---|---|---|---|
| France | 2023-11-14 | 2023-11-14 | |||
| Germany | 2024-01-18 | 2024-01-18 | |||
| Italy | 2023-09-18 | 2023-09-18 | |||
| Spain | 2023-10-30 | 2023-10-30 | |||
| Sweden | 2023-11-24 | 2023-11-24 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-21 | France | Acceptable 2023-07-10
|
2023-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-11 | France | Acceptable 2023-07-10
|
2023-08-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-08-30 | France | Acceptable 2023-07-10
|
2023-08-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-05 | France | Acceptable 2023-12-11
|
2023-12-12 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-12-18 | France | Acceptable 2023-12-11
|
2023-12-18 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-01-17 | France | Acceptable 2023-12-11
|
2024-01-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-15 | France | Acceptable 2024-05-06
|
2024-05-08 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-05-17 | France | Acceptable 2024-05-06
|
2024-05-17 |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-30 | France | Acceptable 2024-11-12
|
2024-11-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-11-18 | France | Acceptable 2024-11-12
|
2024-11-18 |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-21 | France | Acceptable 2025-03-12
|
2025-03-12 |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-28 | France | Acceptable | 2025-05-02 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-28 | Acceptable | 2025-07-07 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-14 | France | Acceptable 2025-08-07
|
2025-08-07 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-28 | France | Acceptable 2025-11-18
|
2025-11-18 |