Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 16, 2021

Primary Completion Date

June 5, 2024

Study Completion Date

June 5, 2026

Conditions
Recurrent Respiratory PapillomatosisPapillomavirus InfectionsPapillomaviridae
Interventions
DRUG

PRGN-2012 - Phase I; Dose Level 1

In Phase 1, dose level 1 of the clinical trial, PRGN-2012 is administered at 1 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery.

DRUG

PRGN-2012 - Phase I; Dose Level 2

In Phase 1, dose level 2 of the clinical trial, PRGN-2012 is administered at 5 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery.

DRUG

PRGN-2012 - Phase II; Dose Level 2

The Phase 2 portion is designed as a dose expansion study where patients are treated at the RP2D of 5 x 10\^11 PU.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Precigen, Inc

INDUSTRY