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CV09050101 mRNA vaccine 12 μg

Phase 1

Glioblastoma | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Feb 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05938387Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or AstrocytomaPHASE1 COMPLETED 37 — — Jun 1, 2023Feb 2, 2026Feb 18, 202613 Belgium, Germany +1
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Study Endpoints
Primary Endpoints
Incidence of treatment-related adverse events (TRAEs)
1 year
Incidence of treatment-emergent adverse events (TEAEs)
1 year
Incidence of serious adverse events (SAEs)
1 year
Incidence of immune related adverse events (irAEs)
1 year
Incidence of injection site reactions (ISRs)
1 year
Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
1 year
Incidence dose-limiting toxicities (DLTs)
Through the first 2 weeks of treatment
Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)
Through the first 2 weeks of treatment
Secondary Endpoints
Time to relapse from the day of surgery until the last scheduled visit of the study
1 year
Progression-Free Survival (PFS) rate from the day of surgery until the last scheduled visit of the study
1 year
Overall survival (OS) rate from the day of surgery until the last scheduled visit of the study
1 year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalation: CVGBM Dose Level -1EXPERIMENTALDose Level -1 represents a dose that may be evaluated if dose level 1 is poorly tolerated. No dose de-escalation below this level is planned for this study. If the dose level -1 is poorly tolerated, the study will be terminated.
Dose escalation: CVGBM Dose Level 1EXPERIMENTAL -
Dose escalation: CVGBM Dose Level 2EXPERIMENTAL -
Dose escalation: CVGBM Dose Level 3EXPERIMENTAL -
Dose escalation: CVGBM Dose Level 4EXPERIMENTAL -
Dose expansionEXPERIMENTALAfter completion of the dose-escalation part and safety data review by the DSMB, approximately 20 patients will be enrolled at the selected Recommended Dose for Expansion (RDE) to generate more data on safety, tolerability and immunogenicity.
Interventions
NameTypeDescription
CV09050101 mRNA vaccine (CVGBM) 12 μgBIOLOGICALCVGBM will be administered as an IM injection.
CV09050101 mRNA vaccine (CVGBM) 25 μgBIOLOGICALCVGBM will be administered as an IM injection.
CV09050101 mRNA vaccine (CVGBM) 50 μgBIOLOGICALCVGBM will be administered as an IM injection.
CV09050101 mRNA vaccine (CVGBM) 100 μgBIOLOGICALCVGBM will be administered as an IM injection.
CV09050101 mRNA vaccine RDE 100 μgBIOLOGICALCVGBM will be administered as an IM injection.
CV09050101 mRNA vaccine (CVGBM) 6 μgBIOLOGICALCVGBM will be administered as an IM injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Histologically confirmed, newly diagnosed GBM (CNS WHO Grade 4) and IDH-wildtype astrocytoma with a molecular signature of "unmethylated" GBM. 2. Specific HLA genotype. 3. Gross total or partial resection (i.e., ≥50% of tumor volume resected). 4. Having completed radiotherapy...

Countries:BelgiumGermanyNetherlands
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