Zopa Retreatment and Vector Shedding in Adults With RRP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrecigen, Inc
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zopapogene imadenovec (Zopa)
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov