NCT06538480 Zopa Retreatment and Vector Shedding in Adults With RRP
| NCT ID | NCT06538480 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Precigen, Inc |
| Condition | Recurrent Respiratory Papillomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2027-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-07-11 with a primary completion date of 2027-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Key Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Amy Lankford, PhD
STUDY DIRECTOR
Precigen, Inc
Frequently Asked Questions
Who can join the NCT06538480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Respiratory Papillomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06538480 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06538480 currently recruiting?
Yes, NCT06538480 is actively recruiting participants. Contact the research team at clinicaltrials@precigen.com for enrollment information.
Where is the NCT06538480 trial being conducted?
This trial is being conducted at Atlanta, United States, Bethesda, United States, Cincinnati, United States.
Who is sponsoring the NCT06538480 clinical trial?
NCT06538480 is sponsored by Precigen, Inc. The principal investigator is Amy Lankford, PhD at Precigen, Inc. The trial plans to enroll 30 participants.