Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
140
Countries
3
Sites
9
Non-Hodgkin Lymphoid Malignancies
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
- 1 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin Lymphoid Malignancies
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 · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 22 | 2 |
| France | Ended | 10 | 3 |
| Spain | Ongoing, recruitment ended | 38 | 4 |
| Rest of world
Australia, Israel
|
— | 70 | — |
Investigational sites
Rigshospitalet
Department of Haematology, Clinical Research Unit, 2081, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Haematological Research unit HFE-X OUH, J B Winsloews Vej 4, 5000, Odense C
Centre Hospitalier Regional Universitaire De Tours
Hematology and cell therapy, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Services des maladies du sang, Rue Michel Polonowski, 59000, Lille
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Hematology, 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 |
|---|---|---|---|---|---|
| Denmark | 2024-03-01 | 2024-03-06 | 2025-11-06 | ||
| Spain | 2024-03-07 | 2024-04-11 | 2025-11-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-19 | Denmark | Acceptable 2024-02-19
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-10 | Denmark | Acceptable 2024-07-11
|
2024-07-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-21 | Denmark | Acceptable 2025-04-01
|
2025-04-02 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-05-13 | Acceptable 2025-04-01
|
2025-07-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-24 | Denmark | Acceptable 2025-11-21
|
2025-11-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-16 | Denmark | Acceptable 2026-03-13
|
2026-03-13 |