Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
3
Advanced PRAME Positive Solid Tumors
Key facts
- Sponsor
- T-Knife GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-02-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced PRAME Positive Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
T-Knife GmbH
- Sponsor organisation
- T-Knife GmbH
- Address
- Robert-Roessle-Strasse 10, Buch Buch
- City
- Berlin
- Postcode
- 13125
- Country
- Germany
Scientific contact point
- Organisation
- T-Knife GmbH
- Contact name
- Michael Loveridge
Public contact point
- Organisation
- T-Knife GmbH
- Contact name
- Michael Loveridge
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 24 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Technische Universitaet Dresden
Early Clinical Trial Unit (NCT/UCC ECTU), Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Med. Klinik m. S. Haematologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
University Medical Center Hamburg-Eppendorf
Zentrum fuer Onkologie, II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-12 | Germany | Acceptable 2026-02-24
|
2026-02-27 |