Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CV09050101 mRNA vaccine 12 μg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose escalation: CVGBM Dose Level -1 | EXPERIMENTAL | Dose 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 1 | EXPERIMENTAL | - |
| Dose escalation: CVGBM Dose Level 2 | EXPERIMENTAL | - |
| Dose escalation: CVGBM Dose Level 3 | EXPERIMENTAL | - |
| Dose escalation: CVGBM Dose Level 4 | EXPERIMENTAL | - |
| Dose expansion | EXPERIMENTAL | After 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. |
| Name | Type | Description |
|---|---|---|
| CV09050101 mRNA vaccine (CVGBM) 12 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
| CV09050101 mRNA vaccine (CVGBM) 25 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
| CV09050101 mRNA vaccine (CVGBM) 50 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
| CV09050101 mRNA vaccine (CVGBM) 100 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
| CV09050101 mRNA vaccine RDE 100 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
| CV09050101 mRNA vaccine (CVGBM) 6 μg | BIOLOGICAL | CVGBM will be administered as an IM injection. |
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...
CV09050101 mRNA vaccine 12 μg is an investigational mRNA vaccine being studied for the treatment of glioblastoma, specifically in adults with newly diagnosed MGMT-unmethylated glioblastoma or astrocytoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
CV09050101 mRNA vaccine 12 μg is an mRNA vaccine designed to encode tumor-associated antigens, aiming to stimulate the immune system to recognize and attack glioblastoma cells. The specific molecular target is not disclosed in the available information, but the vaccine is intended to provoke an anti-tumor immune response.
CV09050101 mRNA vaccine 12 μg is developed by BioNTech SE, a biotechnology company traded on NASDAQ under the ticker BNTX. The company is conducting clinical research on this vaccine for glioblastoma.
CV09050101 mRNA vaccine 12 μg is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the vaccine remains under evaluation for safety and tolerability.
CV09050101 mRNA vaccine 12 μg was studied in a Phase 1 clinical trial with the identifier NCT05938387, titled 'Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma.' The trial enrolled 37 participants across Belgium, Germany, and the Netherlands, and its status is completed.
CV09050101 mRNA vaccine 12 μg is also known as CVGBM, as indicated by the clinical trial title. The trial NCT05938387 refers to the vaccine as CVGBM, and the drug name CV09050101 mRNA vaccine 12 μg is used in the context of this investigational product.