clinical development

In the center of the GAPVAC initiative is a phase I clinical trial for therapy of glioblastoma patients with a number of primary and secondary objectives.

The clinical trial is structured into five work packages (WP). Prior to surgery, GB patients were approached by consortium’s clinical sites (WP5). During surgery, tumor samples were collected that were required for the design of the actively personalized cancer vaccine (APVAC). Enrolled patients were then be treated by standard of care chemoradiotherapy with subsequent immunization with the APVAC that were individually and specifically manufactured according to the patient-specific tumor and immune characteristics (WP6). For a successful implementation of the GAPVAC clinical trial, translational efforts covering regulatory aspects and preparation of GAPVAC clinical documents as part of WP3 began right from the start of GAPVAC within the pre-clinical/translational work program.

Biological activity of each APVAC is monitored for each individual patient by an extensive biomarker and immunomonitoring program (WP7) including the local assessment of tumor-infiltrating lymphocytes (WP8) and peptide:sHLA complexes (WP9). All clinical work packages are performed in parallel and all parties of the consortium collaborate closely in patient recruitment, treatment and monitoring. Safety and feasibility data are analyzed on-time and immunological and biomarker results will be associated to the clinical findings after completion of the clinical trial.