Phase 1b trial of personalized neoantigen-pulsed autologous dendritic cells in newly diagnosed glioblastoma
Limited therapeutic options are available for newly diagnosed glioblastoma (nGBM). A phase 1b trial at Capital Medical University (Beijing, China) evaluated neoantigen-pulsed autologous dendritic cells (ZSNeo-DC) as adjuvant treatment for nGBM. Eleven patients with nGBM received intradermal administration of ZSNeo-DC following surgery and standard chemoradiotherapy. The primary endpoint was safety. Treatment was well tolerated, with adverse events predominantly grade 1 or 2; only two grade 1-2 febrile adverse events were recorded as treatment-related. Secondary endpoint analysis showed that median progression-free survival was 16.2 months, median overall survival was not reached, and 12-months overall survival rate was 100%. A range of 0.7- to 507.0-fold (median 10.3-fold) increase of peripheral neoantigen-specific immune response was observed after the 5th vaccination. Following vaccination, both the activated-to-exhausted ratio of effector/centra memory T cells and the clonal evenness of the T cell receptor repertoire increased significantly in peripheral blood. The authors conclude that ZENeo-DC exhibited a favorable safety profile and preliminary efficacy signal in nGBM.