Zopa Retreatment and Vector Shedding in Adults With RRP
NCT ID: NCT06538480
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-07-11
2028-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 Vector Shedding
Zopa administered subcutaneously at 5 × 10\^11 particle units on Day 1, Week 2, Week 6, and Week 12. Samples for vector shedding to be collected from urine, feces, skin, and nasal tissue.
Zopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Cohort 2 Retreatment
Patients with prior treatment with Zopa (5 × 10\^11 PU per injection) and require clinically indicated debulking procedure
Zopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Interventions
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Zopapogene imadenovec (Zopa)
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Precigen, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Lankford, PhD
Role: STUDY_DIRECTOR
Precigen, Inc
Locations
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Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
National Institute of Health
Bethesda, Maryland, United States
University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Scott Norberg, DO
Role: backup
Other Identifiers
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PRGN-2012-301
Identifier Type: -
Identifier Source: org_study_id
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