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NOT YET RECRUITING
NCT07546669
PHASE4

Efficacy of Zoster Vaccination in Glioblastoma Patients

Sponsor: University Hospital, Essen

View on ClinicalTrials.gov

Summary

In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma. We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.

Official title: Herpes Zoster Vaccine and Autologous CMV-specific T Cells as an Immunomodulatory Adjunct to Standard Neurosurgical Resection Radiochemotherapy in Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2027-01-02

Completion Date

2030-12-31

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

Additional vaccination against shingles (herpes zoster)

Based on patient-preference patients receive autologous CMV-specific T-cells additionally to vaccination contra herpes zoster after completion of radio(chemo-)therapy. Patients included in the experimental arm shall be HLA typed. Up to 6 intravenous infusions of in vitro-expanded T cells at a dose of 2 × 107 cells/m2 body surface area every 2 to 4 weeks shall be administered after clinical assessment. Patients shall continue standard-of-care treatment with temozolomide if indicated. Where possible, administration of autologous T-cells shall be scheduled to fall between chemotherapy treatment weeks to avoid concurrent infusions

OTHER

Standard of care treatment without additional vaccination

Standard of care treatment without additional vaccination