[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557466":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":91,"collaborators":24,"id":93,"slug":24,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":24,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":24,"enrollmentInfo":101,"targetDuration":24,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Precigen, Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Zopapogene imadenovec (Zopa)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 Retreatment","Patients with prior treatment with Zopa (5 × 10\\^11 PU per injection) and require clinically indicated debulking procedure",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Zopapogene imadenovec (Zopa)","Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Amy Lankford, PhD","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Head of Clinical Operations","CONTACT","301-556-9900","clinicaltrials@precigen.com",[36,57,74],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Winship Cancer Institute, Emory University","RECRUITING","Atlanta","Georgia","30322","United States",{"type":44,"coordinates":45},"Point",[46,47],-84.38798,33.749,{"lat":47,"lon":46},[50,54],{"name":51,"role":32,"phone":52,"phoneExt":24,"email":53},"Mosope Oyewole, CRC","404-778-5351","mdoyewo@emory.edu",{"name":55,"role":56,"phone":24,"phoneExt":24,"email":24},"Nabil Saba, MD","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":38,"city":59,"state":60,"zip":61,"country":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"National Institute of Health","Bethesda","Maryland","20892",{"type":44,"coordinates":63},[64,65],-77.10026,38.98067,{"lat":65,"lon":64},[68,72],{"name":69,"role":32,"phone":70,"phoneExt":24,"email":71},"Shannon Householder, RN","240-656-8771","Shannon.householder@nih.gov",{"name":73,"role":32,"phone":24,"phoneExt":24,"email":24},"Scott Norberg, DO",{"facility":75,"status":38,"city":76,"state":77,"zip":78,"country":42,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":44,"coordinates":80},[81,82],-84.51439,39.12711,{"lat":82,"lon":81},[85,89],{"name":86,"role":32,"phone":87,"phoneExt":24,"email":88},"Rebecca Reinert","513-558-1719","gibsonrk@ucmail.uc.edu",{"name":90,"role":56,"phone":24,"phoneExt":24,"email":24},"Aaron Friedman, MD",{"type":92,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100557466",false,"NCT06538480","Zopa Retreatment and Vector Shedding in Adults With RRP","Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis","Key Inclusion Criteria:\n\n* Age 18 years and older.\n* Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.\n* Cohort 1: Treatment-naïve with respect to Zopa.\n* Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\\^11 PU per injection and require clinically indicated debulking procedures.\n* Presence of laryngotracheal papillomas accessible for endoscopic cleanout.\n* ECOG performance status 0 or 1.\n* 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.\n* Ability to understand and sign informed consent.\n\nKey Exclusion Criteria:\n\n* Conditions or therapies that increase risk or interfere with participation per investigator judgment.\n* Systemic corticosteroids \\>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.\n* Other systemic RRP treatments or investigational agents within 30 days.\n* History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.\n* Active uncontrolled HIV, hepatitis B, or hepatitis C infection.\n* Pregnant or nursing women.\n* Known allergy to any study drug component.","ALL","18 Years",{"count":102,"type":103},30,"ESTIMATED","INTERVENTIONAL",[106],"PHASE4","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.",[109,110,111],"Recurrent Respiratory Papillomatosis","Papillomavirus Infection","Papillomaviridae",[113,114,115,116,117,118],"Human Papilloma Virus","laryngotracheal disease","papillomatous disease","Viral Shedding","Retreatment","Zopapogene imadenovec","2025-12-11",{"date":121,"type":122},"2025-12-15","ACTUAL",{"date":124,"type":122},"2024-07-11",{"date":126,"type":103},"2028-12-02",{"name":5,"class":6},3]