[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602402":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":179,"collaborators":10,"id":181,"slug":182,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":10,"eligibilityCriteria":186,"healthyVolunteers":183,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":10,"studyType":193,"phases":10,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Sonoma Biotherapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants exposed to SBT777101 Treg cell therapy",null,"Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)",[13],"Other: Long Term Safety Monitoring Procedures",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","Long Term Safety Monitoring Procedures","In accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy.",[9],[21],{"name":22,"affiliation":23,"role":24},"Sarah Baxter, MD, PhD","Sonoma Biotherapeutics","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Sabrina Fox-Bosetti, MPH","CONTACT","415-992-6245","clinicaloperations@sonomabio.com",{"name":32,"role":28,"phone":29,"phoneExt":10,"email":30},"Jason Do",[34,53,66,81,96,111,122,133,149,164],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"UCSF Medical Center","RECRUITING","San Francisco","California","94143","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-122.41942,37.77493,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":51,"phoneExt":10,"email":52},"Alex 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University","Durham","North Carolina","27708",{"type":43,"coordinates":155},[156,157],-78.89862,35.99403,{"lat":157,"lon":156},[160],{"name":161,"role":28,"phone":162,"phoneExt":10,"email":163},"Laura Van Althuis","919-668-4312","laura.vanalthuis@duke.edu",{"facility":165,"status":135,"city":166,"state":167,"zip":168,"country":40,"countryCode":41,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":43,"coordinates":170},[171,172],-95.36327,29.76328,{"lat":172,"lon":171},[175],{"name":176,"role":28,"phone":177,"phoneExt":10,"email":178},"Stacie Stutte","713-794-1918","snstutte@mdanderson.org",{"type":180,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100602402","a-long-term-follow-up-observational-study-to-evaluate-safety-in-subjects-who-have-received-a-gene-modified-regulatory-t-cell-treg-therapeutic-100602402",false,"NCT07123038","A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic","Inclusion Criteria:\n\n* Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.\n* Subject understands the purpose and risks of the study and is willing to provide written informed consent.\n* Subject is willing to comply with all study procedures for the follow-up period.\n\nExclusion Criteria:\n\n* Participation in the study is not in the subject's best interest, in the opinion of the Investigator","ALL","18 Years","71 Years",{"count":191,"type":192},36,"ESTIMATED","OBSERVATIONAL","To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.",[196,197],"Rheumatoid Arthritis (RA)","Hidradenitis Suppurativa (HS)",[199,200,201,202,203,204,205,206],"Rheumatoid Arthritis","Long Term Follow Up Study","Treg","SBT0000-01","Hidradenitis Suppurativa","SBT777101","SBT777101-01","SBT777101-02","2026-04-15",{"date":209,"type":210},"2026-04-16","ACTUAL",{"date":212,"type":210},"2025-07-22",{"date":214,"type":192},"2040-12",{"name":5,"class":6},10]