Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
5
Acute myeloid leukemia
Key facts
- Sponsor
- Avencell Therapeutics Inc.
- 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
- 29 Jan 2026 → ongoing
- Decision date (initial)
- 2025-09-08
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Avencell Therapeutics Inc.
- Sponsor organisation
- Avencell Therapeutics Inc.
- Address
- 500 Forge Road Suite 320
- City
- Watertown
- Postcode
- 02472-2266
- Country
- United States
Scientific contact point
- Organisation
- Avencell Therapeutics Inc.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Avencell Therapeutics Inc.
- Contact name
- Project Manager
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 10 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Technische Universitaet Dresden
Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Department of Hematology, Oncology and Tumor Immunology, Augustenburger Platz 1, Wedding, Berlin
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Philipps-Universitaet Marburg
Hematology, Oncology, Immunology, Baldingerstrasse, 35043, Marburg
Universitaetsklinikum Ulm AöR
Department of Internal Medicine III, Albert-Einstein-Allee 23, Eselsberg, Ulm
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 | 2026-01-29 | 2026-01-29 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Germany | Acceptable 2025-09-04
|
2025-09-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-21 | Germany | Acceptable | 2025-12-11 |