Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
80
Countries
2
Sites
10
Acute Myeloid Leukemia (AML)
Key facts
- Sponsor
- AvenCell Europe GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 13 Jul 2023 → ongoing
- Decision date (initial)
- 2023-06-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia (AML)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AvenCell Europe GmbH
- Sponsor organisation
- AvenCell Europe GmbH
- Address
- Tatzberg 47, Johannstadt-Nord Johannstadt-Nord
- City
- Dresden
- Postcode
- 01307
- Country
- Germany
Scientific contact point
- Organisation
- AvenCell Europe GmbH
- Contact name
- Armin Ehninger
Public contact point
- Organisation
- AvenCell Europe GmbH
- Contact name
- Project Manager
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 60 | 7 |
| Netherlands | Ongoing, recruiting | 20 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Charite Universitaetsmedizin Berlin KöR
Department of Hematology, Oncology and Tumor Immunology, Augustenburger Platz 1, Wedding, Berlin
Universitatsklinikum Wurzburg AöR
Interdisciplinary Study Center with Early Clinical Trial Unit, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Ulm AöR
Department of Internal Medicine lll, Albert-Einstein-Allee 23, Eselsberg, Ulm
Technische Universitat Dresden
Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Philipps University Marburg
Hematology, Oncology, Immunology, Baldingerstrasse, 35043, Marburg
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Medizinische Hochschule Hannover
Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
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 |
|---|---|---|---|---|---|
| Germany | 2023-07-13 | 2024-01-03 | |||
| Netherlands | 2024-06-21 | 2024-06-24 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-01 | Germany | Acceptable 2023-06-12
|
2023-06-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-12 | Germany | Acceptable | 2023-07-24 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-09-15 | Acceptable 2023-06-12
|
2023-11-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-21 | Germany | Acceptable 2024-04-15
|
2024-04-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-12 | Germany | Acceptable 2024-09-02
|
2024-09-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-17 | Germany | Acceptable 2025-04-29
|
2025-04-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-19 | Germany | Acceptable 2025-11-21
|
2025-11-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-09 | Germany | Acceptable 2026-03-09
|
2026-03-09 |