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Vaccination with Autologous Dendritic cells loaded with Autologous Tumour homogenate in Glioblastoma: a phase II Study (Combi G-Vax)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512493-98-00
Acronym
IRST191.05
Enrollment
28
Registered
2024-07-15
Start date
2021-03-25
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Brief summary

Progression free survival (PFS), measured as the proportion of patients without progression of disease at three months from leukapheresis, Proportion of patients experienced grade 3 or higher adverse events related to the study treatment

Detailed description

Evaluation of the prognostic role of a positive DTH test after at least four vaccine administrations, Overall survival (OS), Ability to enhance the proportion of circulating immune effectors specific for tumor antigens; evaluation of the persistence of an anti-tumor immune response; determination of plasma levels of a panel of inflammatory cytokines and proangiogenic factors; evaluation of the prognostic and predictive role of tumor antigen expression in tumor tissue; analysis of the prognostic and predictive role of immune cells in the peripheral blood and in the tumor microenvironment

Interventions

Sponsors

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS), measured as the proportion of patients without progression of disease at three months from leukapheresis, Proportion of patients experienced grade 3 or higher adverse events related to the study treatment

Secondary

MeasureTime frame
Evaluation of the prognostic role of a positive DTH test after at least four vaccine administrations, Overall survival (OS), Ability to enhance the proportion of circulating immune effectors specific for tumor antigens; evaluation of the persistence of an anti-tumor immune response; determination of plasma levels of a panel of inflammatory cytokines and proangiogenic factors; evaluation of the prognostic and predictive role of tumor antigen expression in tumor tissue; analysis of the prognostic and predictive role of immune cells in the peripheral blood and in the tumor microenvironment

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026