This is a nonrandomized, Phase I/II safety and tolerability study. The safety and tolerability of PRGN-2012 will be assessed following two different dose levels during the Phase I dose escalation trial. In the Phase II portion of the study, treatment with PRGN-2012 at recommended Phase 2 dose (RP2D) will be used to determine the percentage of patients who have an increase in their surgery-free interval (SFI).
This is a Phase I/II study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.