NCT05938387

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

Completed Phase 1 Last updated 18 February 2026

What this trial tests

Phase 1 trial testing CV09050101 mRNA vaccine (CVGBM) 12 μg in Glioblastoma in 37 participants. Completed in 2 February 2026.

Timeline

1 June 2023

Primary endpoint
2 February 2026

2 February 2026

Quick facts

Lead sponsor	CureVac
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 June 2023
Primary completion	2 February 2026
Estimated completion	2 February 2026
Sites	13 locations across Belgium, Netherlands, Germany

Drugs / interventions tested

• CV09050101 mRNA vaccine (CVGBM) 12 μg — full drug profile →
• CV09050101 mRNA vaccine (CVGBM) 25 μg — full drug profile →
• CV09050101 mRNA vaccine (CVGBM) 50 μg — full drug profile →
• CV09050101 mRNA vaccine (CVGBM) 100 μg
• CV09050101 mRNA vaccine RDE 100 μg — full drug profile →
• CV09050101 mRNA vaccine (CVGBM) 6 μg — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

CureVac — full company profile →

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible.

After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy.

The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024.

Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in mRNA-Based Cancer Vaccines.
   Ni L. · · 2023 · cited 33× · PMID 37897001 · DOI 10.3390/vaccines11101599
2. Clinical development of therapeutic mRNA applications.
   Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034
3. Enabling mRNA Therapeutics: Current Landscape and Challenges in Manufacturing.
   Youssef M, Hitti C, Puppin Chaves Fulber J, Kamen AA. · · 2023 · cited 25× · PMID 37892179 · DOI 10.3390/biom13101497
4. Advancing personalized medicine in brain cancer: exploring the role of mRNA vaccines.
   Lin F, Lin EZ, Anekoji M, Ichim TE, et al · · 2023 · cited 22× · PMID 37978542 · DOI 10.1186/s12967-023-04724-0
5. Eliciting antitumor immunity via therapeutic cancer vaccines.
   Peng K, Zhao X, Fu YX, Liang Y. · · 2025 · cited 19× · PMID 40629076 · DOI 10.1038/s41423-025-01316-4
6. Therapeutic approaches to modulate the immune microenvironment in gliomas.
   Sarantopoulos A, Ene C, Aquilanti E. · · 2024 · cited 19× · PMID 39443641 · DOI 10.1038/s41698-024-00717-4
7. Personalized mRNA vaccines in glioblastoma therapy: from rational design to clinical trials.
   Karimi-Sani I, Molavi Z, Naderi S, Mirmajidi SH, et al · · 2024 · cited 18× · PMID 39367418 · DOI 10.1186/s12951-024-02882-x
8. The clinical impact of mRNA therapeutics in the treatment of cancers, infections, genetic disorders, and autoimmune diseases.
   Deyhimfar R, Izady M, Shoghi M, Kazazi MH, et al · · 2024 · cited 17× · PMID 38486748 · DOI 10.1016/j.heliyon.2024.e26971