Actively Recruiting
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Led by Precigen, Inc · Updated on 2025-12-15
30
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, vector shedding, and retreatment effectiveness of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). This open-label phase 4 study includes two groups: one to assess how much and how long the adenoviral vector is shed from urine, feces, skin, and nasal tissue, and another to measure the complete response rate after retreatment with Zopa. Participants receive Zopa by subcutaneous injection at a dose of 5 × 10^11 particle units on Day 1, Week 2, Week 6, and Week 12. Cohort 1 includes patients who have not previously received Zopa and focuses on vector shedding, while Cohort 2 involves patients who have had prior Zopa treatment and require a debulking procedure. Samples for vector shedding are collected from various body sites during treatment. During the study, participants undergo monitoring for vector shedding up to six weeks after the last dose, with additional collections if needed until shedding is undetectable. The complete response rate is evaluated 12 months after the last administration, and the time until the first debulking procedure is tracked for up to three years. Safety and tolerability are monitored up to 28 days after the final dose, with extended follow-up as needed. Participants are involved in multiple visits for injections, sample collection, and ongoing assessments throughout the study period.
CONDITIONS
Brief Title
Zopa Retreatment and Vector Shedding in Adults With RRP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Clinical diagnosis of recurrent respiratory papillomatosis confirmed by histology
- For Cohort 1: no prior treatment with Zopa
- For Cohort 2: received at least four Zopa injections and require debulking procedure
- Presence of laryngotracheal papillomas accessible for endoscopic cleaning
- 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 investigator
- Use of systemic corticosteroids over 10 mg prednisone equivalent or other immunosuppressive drugs 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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Zopapogene imadenovec (Zopa) as 4 subcutaneous injections over a 12-week period.
4 visits for injections on Day 1, Week 2, Week 6, and Week 12
Duration - Up to 12 months or longer depending on cohort
Participants are followed for safety monitoring and evaluation of vector shedding or clinical response after treatment ends.
Visits up to 6 weeks post-treatment for vector shedding assessments; additional visits up to 12 months for clinical response and safety monitoring
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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