Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
54
Countries
3
Sites
13
Surgically Resected Glioblastoma (GBM) or Astrocytoma with a Molecular Signature of Unmethylated Glioblastoma
Key facts
- Sponsor
- Curevac AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 May 2023 → 2 Feb 2026
- Decision date (initial)
- 2023-03-27
- 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
Surgically Resected Glioblastoma (GBM) or Astrocytoma with a Molecular Signature of Unmethylated Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
| 21.0 | PT | 10060971 | Astrocytoma malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Curevac AG
- Sponsor organisation
- Curevac AG
- Address
- Schumannstrasse 27, Westend-Sued Westend-Sued
- City
- Frankfurt Am Main
- Postcode
- 60325
- Country
- Germany
Scientific contact point
- Organisation
- Curevac AG
- Contact name
- Clinical Trials Information
Public contact point
- Organisation
- Curevac AG
- Contact name
- Clinical Trials Information
Locations
3 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 2 |
| Germany | Ended | 30 | 10 |
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
UZ Brussel
Medische oncologie, Laarbeeklaan 101, 1090, Jette
CHU De Liège
Domaine Universitaire du Sart-Tilman, Avenue De L'hopital 1, 4000, Liege
Goethe University Frankfurt
Neuroonkologie, Schleusenweg 2-16, Niederrad, Frankfurt Am Main
Heidelberg University Hospital AöR
Neurologische Klinik, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen
Abteilung Neurologie mit interdisziplinärem, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Universitatsklinikum Leipzig AöR
Klinik und Poliklinik für Strahlentherapie, Stephanstrasse 9a, Zentrum-Suedost, Leipzig
Medical Center - University Of Freiburg
Klinik für Strahlenheilkunde, Robert-Koch-Straße 3, Stühlinger, Freiburg Im Breisgau
Universitaetsklinikum Regensburg
Klinik und Poliklinik für Neurologie-NeuroOnkologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Bonn AöR
Neuroonkologie, Venusberg-Campus 1, Venusberg, Bonn
Klinikum der Universitaet Muenchen AöR
Neurochirurgische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Universitat Heidelberg
Neurologische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Essen AöR
Abteilung Klinische Neuroonkologie Klinik für Neurologie, Hufelandstrasse 55, Holsterhausen, Essen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2023-05-25 | 2026-01-20 | 2023-05-31 | 2025-01-28 | |
| Germany | 2023-05-05 | 2026-02-02 | 2023-05-09 | 2025-02-05 | |
| Netherlands | 2023-08-25 | 2025-12-04 | 2023-08-30 | 2024-12-10 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-21 | Germany | No conclusion 2023-03-13
|
2023-03-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-04-28 | No conclusion | 2023-06-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-03 | No conclusion | 2023-05-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-05-04 | Germany | No conclusion | 2023-06-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-19 | Germany | Acceptable 2024-06-10
|
2024-06-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-18 | Germany | Acceptable | 2024-07-24 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-05 | Acceptable | 2024-08-19 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-29 | Germany | 2024-08-29 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-23 | Germany | Acceptable | 2025-01-06 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-04-25 | Germany | Acceptable 2025-07-14
|
2025-07-16 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-15 | Germany | Acceptable 2025-07-14
|
2025-09-15 |