Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
136
Countries
3
Sites
11
Non-Hodgkin Lymphoid Malignancies (NHLs)
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin Lymphoid Malignancies (NHLs)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 13 | 2 |
| France | Ongoing, recruiting | 24 | 4 |
| Spain | Ongoing, recruiting | 28 | 5 |
| Rest of world
Australia, Turkey
|
— | 71 | — |
Investigational sites
Universitair Ziekenhuis Antwerpen
Hematology, Drie Eikenstraat 655, 2650, Edegem
Centre hospitalier universitaire de Liege
Hematology, Avenue De L'Hopital 1, 4000, Liege
Assistance Publique Hopitaux De Paris
Clinical hematology & cellular therapy, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Oncopole Claudius Regaud
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Blood diseases, Rue Michel Polonowski, 59000, Lille
Hospices Civils De Lyon
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Hospital Universitario Hm Sanchinarro
Hematología, Calle Ona 10, 28050, Madrid
Hospital Clinic De Barcelona
Hematología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Hematología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Hematología, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Hematología, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Belgium | 2026-02-27 | 2026-03-13 | |||
| France | 2026-06-08 | 2026-06-25 | |||
| Spain | 2026-06-04 | 2026-06-11 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-08 | Belgium | Acceptable 2026-02-26
|
2026-02-26 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2026-03-11 | Acceptable 2026-02-26
|
2026-05-21 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-03-11 | 2026-06-04 |