Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
1
non-Hodgkin Lymphomas Subtypes: DLBCL - ORPHA: 544 Agressive B-cell non-Hodgkin lymphoma ORPHA: 300846 High grade B-cell lymphoma with MYCand/or BCL2 and/or BCL6 rearrangement ORPHA: 480541
Key facts
- Sponsor
- Wroclaw Medical University
- 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
- 25 Jun 2025 → ongoing
- Decision date (initial)
- 2025-03-27
- 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
non-Hodgkin Lymphomas Subtypes: DLBCL - ORPHA: 544 Agressive B-cell non-Hodgkin lymphoma ORPHA: 300846 High grade B-cell lymphoma with MYCand/or BCL2 and/or BCL6 rearrangement ORPHA: 480541
| 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
Wroclaw Medical University
- Sponsor organisation
- Wroclaw Medical University
- Address
- Ul. Wybrzeze Ludwika Pasteura 1
- City
- Wroclaw
- Postcode
- 50-367
- Country
- Poland
Scientific contact point
- Organisation
- Wroclaw Medical University
- Contact name
- Information desk
Public contact point
- Organisation
- Wroclaw Medical University
- Contact name
- Information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | 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 |
|---|---|---|---|---|---|
| Poland | 2025-06-25 | 2025-06-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Poland | Acceptable 2025-03-24
|
2025-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Poland | Not acceptable 2025-09-08
|
2025-09-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-29 | Poland | Acceptable 2026-03-07
|
2026-03-13 |