CTIM-07. PHASE II RANDOMIZED, BLINDED, PLACEBO-CONTROLLED TRIAL TESTING PP65 CMV MRNA DENDRITIC CELL VACCINE AND TETANUS-DIPHTHERIA TOXOID FOR NEWLY DIAGNOSED GBM (ATTAC II, NCT02465268)

Abstract INTRODUCTION Immunotherapy is limited in efficacy for glioblastoma (GBM). The objective of this study was to evaluate the and immune effects pp65 mRNA dendritic cell (DC) vaccine with use lysosomal-associated membrane protein (LAMP) two different formulations (full-length (fl) short-length (sh). METHODS Patients who underwent resection newly diagnosed GBM were enrolled randomized one 3 arms: Arm 1) pp65-shLAMP DC GM-CSF, 2) pp65-flLAMP 3) Unpulsed peripheral blood mononuclear cells (PBMC). After surgery, patients leukapheresis PBMC isolation vaccines generation. treated standard radiation temozolomide followed by dose intensified adjuvant at 75-100 mg/m2 x 21 days (aged less than 70) or 150-200 5 (patients 70 older). Immunization started 22-24 cycle #1 1-3 delivered 2 week intervals. All received tetanus-toxoid booster prior 1. continued receive monthly up 10 tetanus-diphtheria toxoid skin prep 3, 6 9 (arms 1 2). Safety, labs evaluated. RESULTS Overall well-tolerated SAEs possibly attributed vaccination that met criteria as DLTs. Of recorded grade lower AEs, attributable vaccination. One patient removed from due failure produce QA/QC release criteria. CONCLUSION In a large blinded cohort, delivery CMV LAMP feasible safe multi-institutional setting. primary endpoint survival will be analyzed conclusion study.