Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
150
Countries
4
Sites
11
various B-cell malignancies
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
- 29 Feb 2024 → ongoing
- Decision date (initial)
- 2023-10-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-503136-13-00
- ClinicalTrials.gov
- NCT05618028
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
various B-cell malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
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
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 2 |
| France | Ongoing, recruitment ended | 16 | 2 |
| Germany | Ended | 16 | 2 |
| Spain | Ongoing, recruitment ended | 40 | 5 |
| Rest of world
United Kingdom, Israel, Australia, United States, Taiwan, Korea, Republic of
|
— | 62 | — |
Investigational sites
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonovski, 59037, Lille Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik für Hämatologie, Onkologie, Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
University Hospital Cologne AöR
Klinik I fuer Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2024-03-19 | 2024-08-29 | 2026-03-08 | ||
| France | 2024-02-29 | 2024-04-05 | 2026-03-08 | ||
| Germany | 2024-08-29 | ||||
| Spain | 2024-04-10 | 2024-07-04 | 2026-03-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-26 | Germany | Acceptable 2023-10-16
|
2023-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-25 | Germany | Acceptable 2024-06-21
|
2024-06-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-18 | Germany | Acceptable 2025-03-24
|
2025-03-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-14 | Germany | Acceptable 2025-10-27
|
2025-10-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-02 | Acceptable 2026-03-20
|
2026-03-20 |