Status:
RECRUITING
Zopa Retreatment and Vector Shedding in Adults With RRP
Lead Sponsor:
Precigen, Inc
Conditions:
Recurrent Respiratory Papillomatosis
Papillomavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 enrolle...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06538480
Start Date
July 11 2024
End Date
December 2 2028
Last Update
December 15 2025
Active Locations (3)
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1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
2
National Institute of Health
Bethesda, Maryland, United States, 20892
3
University of Cincinnati
Cincinnati, Ohio, United States, 45267