Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
160
Countries
2
Sites
4
relapsed or refractory B‑cell non-Hodgkin lymphomas
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
- 24 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-03
- 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
relapsed or refractory B‑cell non-Hodgkin lymphomas
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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 12 | 1 |
| Poland | Ongoing, recruitment ended | 18 | 3 |
| Rest of world
China, Japan, Turkey, Korea, Republic of, Taiwan
|
— | 130 | — |
Investigational sites
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UO Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Pratia Hematologia Sp. z o.o.
NA, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
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 | 2024-08-01 | 2024-12-05 | 2026-01-27 | ||
| Poland | 2024-07-24 | 2024-11-13 | 2026-01-27 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-13 | Italy | Acceptable 2024-07-01
|
2024-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Acceptable | 2024-11-27 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-25 | Italy | Acceptable with conditions 2025-12-01
|
2025-12-01 |