NCT06538480PHASE4Recruiting
Zopa Retreatment and Vector Shedding in Adults With RRP
Precigen, Inc
Start Date
7/11/2024
Completion Date
12/2/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
Zopapogene imadenovec (Zopa)
Conditions
Recurrent Respiratory PapillomatosisPapillomavirus InfectionPapillomaviridae
Locations
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
National Institute of Health
Bethesda, Maryland 20892
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States