Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
1
Male and female adult patients with relapsed Multiple Myeloma or Diffuse large B-cell Non-Hodgkin’s Lymphoma shall be treated in the trial.
Key facts
- Sponsor
- Technische Universitat Dresden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Feb 2024 → ongoing
- Decision date (initial)
- 2023-11-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502831-20-00
- ClinicalTrials.gov
- NCT05836896
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Male and female adult patients with relapsed Multiple Myeloma or Diffuse large B-cell Non-Hodgkin’s Lymphoma shall be treated in the trial.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Technische Universitat Dresden
- Sponsor organisation
- Technische Universitat Dresden
- Address
- Mommsenstrasse 11, Raecknitz/zschertnitz Raecknitz/zschertnitz
- City
- Dresden
- Postcode
- 01069
- Country
- Germany
Scientific contact point
- Organisation
- Technische Universitat Dresden
- Contact name
- Prof. Dr. Martin Wermke
Public contact point
- Organisation
- Technische Universitat Dresden
- Contact name
- Prof. Dr. Martin Wermke
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 16 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-02-15 | 2024-02-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-21 | Germany | Acceptable 2023-11-02
|
2023-11-03 |