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

Summary

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.

Timeline

Start

2023-06-01

Primary completion

2026-02-02

Completion

2026-02-02

Publications

• Lutz J, Feist RK, Sonntag T, Peguero-Sanchez E, Wolter K, Bick R, Bauer J, Walz JS, Heidenreich R. Preclinical development of an mRNA-based multiepitope immunotherapeutic for glioblastoma. Cancer Immunol Immunother. 2025 Oct 6;74(11):329. doi: 10.1007/s00262-025-04178-x.

Drugs

Indications