[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637819":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":31,"responsibleParty":47,"collaborators":31,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":31,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":31,"enrollmentInfo":58,"targetDuration":31,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":82,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":31},{"fullName":5,"class":6},"YolTech Therapeutics Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"YOLT-203","EXPERIMENTAL","Participants will receive both study treatments in sequential treatment periods according to randomized assignment. Participants who initially receive YOLT-203 during the double-blind treatment period and will cross over to the placebo treatment in the subsequent treatment period, followed by safety and efficacy follow-up.",[13],"Genetic: YOLT-203",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive both study treatments in sequential treatment periods according to randomized assignment. Participants who initially receive placebo during the double-blind treatment period and will cross over to the YOLT-203 treatment in the subsequent treatment period, followed by safety and efficacy follow-up.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"GENETIC","YOLT-203 is an investigational gene editing therapy being evaluated for the treatment of Primary Hyperoxaluria Type 1 (PH1). It is administered by intravenous infusion over 1 hour.",[9],[26],"Investigational Gene Editing Therapy",{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Placebo is a matching intravenous infusion administered over 1 hour.",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Ling Xiao, MD, PhD","YolTech Therapeutics","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Kim Marie Grabbe, MS, MBA","CONTACT","217-851-5818","Kim.Marie.Grabbe@yoltx.com",{"name":44,"role":40,"phone":45,"phoneExt":31,"email":46},"Claudia Rainolter","412-227-1722","claudia.rainolter@yoltx.com",{"type":48,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100637819","phase-2-study-of-yolt-203-in-children-and-adults-with-primary-hyperoxaluria-type-1-ph1-100637819",false,"NCT07587021","Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)","A Randomized, Double-blind, Placebo-controlled Study Followed by a Treatment Extension to Evaluate the Efficacy and Safety of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1","Inclusion Criteria\n\n* You are 6 years old or older.\n* You have been diagnosed with PH1 (primary hyperoxaluria type 1) through genetic testing.\n* Urine tests show that your oxalate levels are not within certain limits (based on at least two 24-hour urine collections).\n* If you take vitamin B6, your dose has been stable for at least 3 months, and you are willing to keep it the same during the study.\n* You (and\u002For your parent or legal guardian, if you are under 18) understand the study and agree to follow all study requirements, including signing a consent form.\n\nExclusion Criteria\n\n* You have signs that oxalate has affected parts of your body outside the kidneys.\n* Your liver blood tests are not within certain limits.\n* You have certain abnormal blood clotting results (unless controlled with medication like warfarin).\n* You have HIV, or active or chronic hepatitis C.\n* You are pregnant, planning to become pregnant, or breastfeeding.\n* You are not willing to use birth control during the study and for 6 months after (if applicable).\n* You are unable to limit alcohol intake to no more than about 2 drinks per day.\n* You have had alcohol or drug abuse in the past year.\n* You are unable to follow standard treatments for PH1 (such as drinking plenty of fluids, taking prescribed medications like potassium citrate, or following dietary advice).","ALL","6 Years",{"count":59,"type":60},36,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1.\n\nAfter the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion.",[66,67],"Primary Hyperoxaluria Type 1","PH1",[69,70,71,72,73,74,75,9,76,77,78,79,80,81],"ph1","primary hyperoxaluria Type 1","yoltech","yolt203","primary hyperoxaluria","recurrent kidney stones","rare kidney stones","genetic kidney stones","gene editing","gene therapy","AGXT gene","CRISPR-Cas9","Alanine Glyoxylate Aminotransferase Gene","NOT_YET_RECRUITING","2026-05-07",{"date":85,"type":86},"2026-05-14","ACTUAL",{"date":88,"type":60},"2026-06",{"date":90,"type":60},"2028-02",{"name":5,"class":6}]