[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569834":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":59,"collaborators":19,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":19,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":19,"maxAge":19,"enrollmentInfo":71,"targetDuration":19,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1","Teclistamab monotherapy",[12],"Drug: Teclistamab (Tec)",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Teclistamab (Tec)","Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg\u002Fkg and 1.5 mg\u002Fkg in Cycle 1 (2-4 days between doses). 3 mg\u002Fkg every 4 weeks will be used in subsequent cycles.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jin Lu, M.D.","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Yang Dr, M.D.","CONTACT","+86-10-88326542","pkuphliuyang@bjmu.edu.cn",[31,49],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Peking University Peoples Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":19,"email":29},"Yang Liu, Dr","86-13716926210",{"facility":50,"status":33,"city":34,"state":19,"zip":19,"country":37,"countryCode":38,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"Fuxing Hospital affiliated to Capital Medical University",{"type":40,"coordinates":52},[42,43],{"lat":43,"lon":42},[55],{"name":56,"role":27,"phone":57,"phoneExt":19,"email":58},"Liru Wang","010-18618238652","wanglirumail@126.com",{"type":23,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":19,"oldOrganization":19},"Jin Lu, MD","Dr","Peking University","100569834","prospective-study-of-teclistamab-in-the-treatment-of-systemic-al-amyloidosis-100569834",false,"NCT06699394","Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis","Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study","Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;\n3. Life expectancy greater than 12 weeks;\n4. HGB ≥70g\u002FL;\n5. Blood oxygen saturation \\> 90%;\n6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n7. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","ALL",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.\n\nThis is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.",[79],"AL Amyloidosis",[81,82],"teclistamab","complete hematological response","2025-04-20",{"date":85,"type":86},"2025-04-24","ACTUAL",{"date":88,"type":86},"2025-03-29",{"date":90,"type":73},"2026-12-31",{"name":5,"class":6},2]