Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma - Trial NCT05938387

Timeline & Enrollment

Primary Outcome

Incidence of treatment-related adverse events (TRAEs),Incidence of treatment-emergent adverse events (TEAEs),Incidence of serious adverse events (SAEs),Incidence of immune related adverse events (irAEs),Incidence of injection site reactions (ISRs),Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0,Incidence dose-limiting toxicities (DLTs),Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)

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 will consist of a dose-escalation part (Part A) and a dose-expansion part (Part B).
 
 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

ICD-10 Classifications