Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
1
Relapsed/refractory CD123+ hematological malignancies: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm, Acute Lymphoblastic Leukemia.
Key facts
- Sponsor
- Institute Of Hematology And Blood Transfusion
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 23 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory CD123+ hematological malignancies: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm, Acute Lymphoblastic Leukemia.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10024324 | Leukaemias | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute Of Hematology And Blood Transfusion
- Sponsor organisation
- Institute Of Hematology And Blood Transfusion
- Address
- U Nemocnice 2094/1, Nove Mesto Nove Mesto
- City
- Prague
- Postcode
- 128 00
- Country
- Czechia
Scientific contact point
- Organisation
- Institute Of Hematology And Blood Transfusion
- Contact name
- Dr. Petr Lesný, Imunoterapie ÚHKT
Public contact point
- Organisation
- Institute Of Hematology And Blood Transfusion
- Contact name
- Information site
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Czechia | 2024-10-23 | 2024-10-23 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-30 | Czechia | Acceptable 2024-09-02
|
2024-09-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-21 | Czechia | Acceptable 2024-09-02
|
2026-05-21 |