[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585567":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Sichuan Provincial People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13,14],"Biological: CM313 injection","Biological: glucocorticoids",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","CM313 injection","600 mg (4 mL per vial), administer once at Week 0, 1, and 2, and then every 6 months thereafter or determined based on clinical assessment",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"glucocorticoids","Administer medium- or long-acting glucocorticoids 1-3 hours before injection",[9],[26],{"name":27,"affiliation":5,"role":28},"Jianing Yang","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},"CONTACT","+86-17708130389","dryangjn@163.com",[35],{"facility":5,"status":11,"city":36,"state":11,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Chengdu","China","CN",{"type":40,"coordinates":41},"Point",[42,43],104.06667,30.66667,{"lat":43,"lon":42},[46],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},{"type":28,"investigatorFullName":27,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Head of Dermatology","100585567","a-single-center-study-of-cm313-in-patients-with-pemphigus-100585567",false,"NCT06904040","A Single-center Study of CM313 in Patients With Pemphigus","A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus","Inclusion Criteria:\n\n* Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ Positive Nikolsky's sign.\n* Adult patients aged between 18 and 80 years old.\n* Moderate - to - severe pemphigus vulgaris\u002Ffoliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.\n\nExclusion Criteria:\n\n* Pregnant or lactating women and women planning to conceive.\n* Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.\n* Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.","ALL","18 Years","80 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"NA","A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.",[67],"Pemphigus","NOT_YET_RECRUITING","2025-03-25",{"date":71,"type":72},"2025-04-01","ACTUAL",{"date":71,"type":61},{"date":75,"type":61},"2028-04-01",{"name":5,"class":6},1]