Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
32
Countries
1
Sites
1
Acute myeloid leukemia
Key facts
- Sponsor
- Miltenyi Biomedicine GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Aug 2024 → ongoing
- Decision date (initial)
- 2023-12-18
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Miltenyi Biomedicine GmbH
- Sponsor organisation
- Miltenyi Biomedicine GmbH
- Address
- Friedrich-Ebert-Strasse 68, Moitzfeld Moitzfeld
- City
- Bergisch Gladbach
- Postcode
- 51429
- Country
- Germany
Scientific contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Public contact point
- Organisation
- Miltenyi Biomedicine GmbH
- Contact name
- Clinical Trial Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Academisch Ziekenhuis Leiden
Department of Hematology, Albinusdreef 2, 2333 ZA, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-08-01 | 2025-01-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Netherlands | Acceptable 2023-12-11
|
2023-12-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | Netherlands | Acceptable 2025-05-26
|
2025-05-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-29 | Netherlands | Acceptable 2025-05-26
|
2025-07-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-28 | Netherlands | Acceptable 2026-03-30
|
2026-03-30 |