Introduction
tumor, head and neck cancers, toxicity, advanced-stage, HNCs, vulvar cancer
TUMOR, SOLID TUMORS, HUMAN PAPILLOMA VIRUS, HEAD AND NECK CANCER, VULVAR CANCER
The human papilloma virus (HPV) is the most common sexually transmitted infection in the United States and is estimated to cause over 44,000 cases of anal, cervical, head and neck cancers (HNCs), penile, vaginal, and vulvar cancer yearly [Microfluidic squeezing (Cell SqueezeUsing the murine TC-1 tumor model that expresses HPV16 proteins E6 and E7 [The investigational product SQZ-PBMC-HPV consists of autologous PBMCs presenting immunogenic epitopes of E6 and E7 on HLA-A*02, with the cell mixture consisting primarily of T cells, B cells, natural killer cells, and monocytes. HLA-A*02 is one of the most common MHC-I haplotypes in the United States, ranging from 20 – 30% prevalence depending on ethnic subgroup [Here we present a Phase 1 study (SQZ-PBMC-HPV-101; NCT04084951) assessing the safety and tolerability of SQZ-PBMC-HPV in patients with advanced-stage, previously treated, HPV16+ solid tumors. Safety results, including dose limiting toxicity (DLT), are included. We report changes in blood cytokines after administration of SQZ-PBMC-HPV, and paired biopsies were characterized for pharmacodynamics effects.