Actively Recruiting
Zopa Retreatment and Vector Shedding in Adults With RRP
Led by Precigen, Inc · Updated on 2025-12-15
30
Participants Needed
3
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zopa Retreatment and Vector Shedding in Adults With RRP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation
- Cohort 1 participants must be treatment-na�efve to Zopa
- Cohort 2 participants must have received at least four Zopa injections at 5 �d7 10^11 PU per injection and need debulking procedures
- Presence of laryngotracheal papillomas accessible for endoscopic cleanout
- ECOG performance status of 0 or 1
- Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days (males) or 6 months (females) after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Conditions or therapies that increase risk or interfere with participation as judged by the investigator
- Use of systemic corticosteroids over 10 mg prednisone equivalent or other immunosuppressive medications within 14 days before dosing
- Use of 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 component of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
National Institute of Health
Bethesda, Maryland, United States, 20892
Actively Recruiting
3
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here