Recurrent Respiratory PapillomatosisPhase 4NCT06538480
Zopa Retreatment and Vector Shedding in Adults With RRP
A Phase 4 study testing Zopapogene imadenovec (Zopa) in people with Recurrent Respiratory Papillomatosis and Papillomavirus Infection, run by Precigen, Inc at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Respiratory Papillomatosis, Papillomavirus Infection, Papillomaviridae
- What is being tested?
- Zopapogene imadenovec (Zopa)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2024to 2 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Mosope Oyewole, CRC, 404-778-5351, mdoyewo@emory.edu
Nabil Saba, MD
- Recruiting
National Institute of Health
Bethesda, Maryland, 20892
Shannon Householder, RN, 240-656-8771, Shannon.householder@nih.gov
Scott Norberg, DO
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Rebecca Reinert, 513-558-1719, gibsonrk@ucmail.uc.edu
Aaron Friedman, MD
About this study
Official title: Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
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.
- Being tested
- Zopapogene imadenovec (Zopa)
- Keywords
- Human Papilloma Virus, laryngotracheal disease, papillomatous disease, Viral Shedding, Retreatment, Zopapogene imadenovec
- Medical subject headings
- Recurrent respiratory papillomatosis, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zopapogene imadenovec (Zopa)Drug
Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Vector Shedding | Experimental | 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. Receives: Drug: Zopapogene imadenovec (Zopa) |
| Cohort 2 Retreatment | Experimental | Patients with prior treatment with Zopa (5 × 10^11 PU per injection) and require clinically indicated debulking procedure Receives: Drug: Zopapogene imadenovec (Zopa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 Vector shedding
Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue
Measured: Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection
Cohort 2 Complete Response Rate
Percentage of subjects achieving a complete response defined as no clinically indicated debulking procedures during the 12 months following completion of Zopa retreatment.
Measured: 12 months following last administration
Secondary outcomes (2)
Interval to First Debulking Procedure (Cohort 2)
Determine the interval to the first debulking procedure following retreatment with Zopapogene imadenovec (Zopa).
Measured: 3 years following last administration
Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)
Assess the safety and tolerability of Zopa in adult subjects with recurrent respiratory papillomatosis (RRP), including incidence and severity of adverse events graded per CTCAE v5.0.
Measured: Up to 28 days after last administration, with extended monitoring during follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start11 Jul 2024
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precigen, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Lankford, PhD, Study director, Precigen, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538480
- Sponsor's protocol ID
- PRGN-2012-301
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
- ClinicalTrials.gov ID
- NCT06538480
- Acronym / sponsor ID
- PRGN-2012-301
- Keywords
- Human Papilloma Virus, laryngotracheal disease, papillomatous disease, Viral Shedding, Retreatment, Zopapogene imadenovec
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Precigen, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Vector Shedding | Experimental | Drug: Zopapogene imadenovec (Zopa)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. |
| Cohort 2 Retreatment | Experimental | Drug: Zopapogene imadenovec (Zopa)Patients with prior treatment with Zopa (5 × 10^11 PU per injection) and require clinically indicated debulking procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zopapogene imadenovec (Zopa)Zopa will be administered as 4 subcutaneous administrations over a 12-week interval. | Drug | Cohort 1 Vector Shedding, Cohort 2 Retreatment |
Primary outcome
Cohort 1 Vector shedding
Time frame: Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection
Magnitude and duration of Zopa vector shedding measured in urine, fecal, skin, and nasal tissue
Cohort 2 Complete Response Rate
Time frame: 12 months following last administration
Percentage of subjects achieving a complete response defined as no clinically indicated debulking procedures during the 12 months following completion of Zopa retreatment.
2 secondary outcomes
Interval to First Debulking Procedure (Cohort 2)
Time frame: 3 years following last administration
Safety and Tolerability of Zopa (Cohort 1 and Cohort 2)
Time frame: Up to 28 days after last administration, with extended monitoring during follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Recurrent Respiratory Papillomatosis
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruitingPhase 2
Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Tract Diseases, Neoplasms
Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1/2
Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
Recurrent Respiratory Papillomatosis (RRP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Lankford, PhD study director
Precigen, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zopapogene imadenovec (Zopa) in people with Recurrent Respiratory Papillomatosis and Papillomavirus Infection, run by Precigen, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Operations (301-556-9900, clinicaltrials@precigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 Vector shedding (time frame: Up to 6 weeks following last administration, with additional collections if needed until two consecutive measurements at or below limit of detection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.