Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
157
Countries
3
Sites
7
Non-Hodgkin's Lymphoma
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 22 Sep 2025
- Decision date (initial)
- 2025-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512586-13-00
- ClinicalTrials.gov
- NCT06667687
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin's Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 16 | 2 |
| Spain | Ended | 24 | 3 |
| Sweden | Ended | 16 | 2 |
| Rest of world
United States, Israel, Japan, Australia, United Kingdom
|
— | 101 | — |
Investigational sites
Rigshospitalet
1202: Department of Haematology and Phase 1 Unit., Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
1201: Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Hospital Universitario Hm Sanchinarro
9003: Hematología, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
9002: Hematología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
9001: Hematología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-29 | Denmark | Acceptable with conditions 2025-08-07
|
2025-08-11 |