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Zopa Retreatment and Vector Shedding in Adults With RRP

RecruitingPhase 4

Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Precigen, Inc · Participants: 30 · Started: Jul 11, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06538480

Locations in the U.S.

GeorgiaWinship Cancer Institute, Emory University, Atlanta
MarylandNational Institute of Health, Bethesda
OhioUniversity of Cincinnati, Cincinnati

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.