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Zopa Retreatment and Vector Shedding in Adults With RRP
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Age 18 years and older. * Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma. * Cohort 1: Treatment-naïve with respect to Zopa. * Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\^11 PU per injection and require clinically indicated debulking procedures. * Presence of laryngotracheal papillomas accessible for endoscopic cleanout. * ECOG performance status 0 or 1. * Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days for males and 6 months for females after last dose. * Ability to understand and sign informed consent. Key Exclusion Criteria: * Conditions or therapies that increase risk or interfere with participation per investigator judgment. * Systemic corticosteroids \>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing. * Other systemic RRP treatments or investigational agents within 30 days. * History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia. * Active uncontrolled HIV, hepatitis B, or hepatitis C infection. * Pregnant or nursing women. * Known allergy to any study drug component.
About the study
This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.
What is being tested
- Zopapogene imadenovec (Zopa) (drug)
Sponsor: Precigen, Inc · Participants: 30 · Started: Jul 11, 2024
Contact the study team
- Head of Clinical Operations · Phone: 301-556-9900
Official record on ClinicalTrials.gov — NCT06538480
Locations in the U.S.
| Georgia | Winship Cancer Institute, Emory University, Atlanta |
| Maryland | National Institute of Health, Bethesda |
| Ohio | University of Cincinnati, Cincinnati |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.