Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
108
Countries
2
Sites
6
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
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 13 | 2 |
| France | Authorised, recruitment pending | 24 | 4 |
| Rest of world
Turkey, Australia
|
— | 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
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 |
Application history
2 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 |