Zopapogene imadenovec for Recurrent Respiratory Papillomatosis
Zopa Retreatment and Vector Shedding in Adults With RRP
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Precigen, Inc · Industry
This trial is looking for adults with recurrent respiratory papillomatosis. Participants will receive a treatment called Zopapogene imadenovec and help researchers learn more about its effects.
You may be able to join if
- I am 18 years or older.
- I have been diagnosed with recurrent respiratory papillomatosis.
- I have not received Zopa treatment before if in Cohort 1.
- I have received at least four Zopa treatments and need further procedures if in Cohort 2.
- I have growths in my throat that can be cleaned out.
- I am in good health (ECOG performance status 0 or 1).
- I can understand and sign informed consent.
- I will use contraception during and after treatment if I can get pregnant.
You may not be able to join if
- I have conditions or therapies that increase risk according to the doctor.
- I have taken more than 10 mg of prednisone or other immunosuppressants in the last 14 days.
- I have had other RRP treatments or investigational drugs in the last 30 days.
- I have a history of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.
- I have active HIV, hepatitis B, or hepatitis C.
- I am pregnant or nursing.
- I am allergic to any study drug component.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityThis 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.
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