[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537634":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":67,"collaborators":19,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":19,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Kanglin Biotechnology (Hangzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KL003 Cell Injection Drug Product","EXPERIMENTAL","Transplant of auto-HSC transduced with lentiviral vector encoding βA-T87Q-globin gene",[13],"Drug: KL003 Cell Injection Drug Product",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administered by intravenous infusion after myeloablative conditioning with busulfan.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Haoquan Wu, PhD","R&D Kanglin Biotech","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"jingfeng Yan","CONTACT","+86 18852138866","yanjingfeng@kanglinbio.com",[32,51],{"facility":33,"status":34,"city":35,"state":36,"zip":19,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46,49],{"name":47,"role":28,"phone":48,"phoneExt":19,"email":19},"Wei Tang, PhD","+86 13472889588",{"name":50,"role":28,"phone":19,"phoneExt":19,"email":19},"Saijuan Chen, PhD",{"facility":52,"status":34,"city":53,"state":54,"zip":19,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Institute of Hematology & Blood Diseases Hospital","Tianjin","Tianjin Municipality",{"type":40,"coordinates":56},[57,58],117.17667,39.14222,{"lat":58,"lon":57},[61,65],{"name":62,"role":28,"phone":63,"phoneExt":19,"email":64},"Zhen Gao, Master","+86 15522360862","Gaozhen@ihcams.ac.cn",{"name":66,"role":28,"phone":19,"phoneExt":19,"email":19},"Jun Shi, PhD",{"type":68,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100537634","phase-1--thalassemia-treatment-with-kl003-cell-injection-100537634",false,"NCT06280378","Β-Thalassemia Treatment with KL003 Cell Injection","A Phase I\u002FII Clinical Study Evaluating the Safety and Efficacy of KL003 Cell Injection in Transfusion-dependent Β-thalassemia","Inclusion Criteria:\n\n* Male or female age between 3-35 years;\n* Diagnosis of transfusion-dependent β-thalassemia and a history of at least 100 mL\u002Fkg\u002Fyear of pRBCs or ≥8 transfusions of pRBCs per year for the prior 2 years;\n* Karnofsky performance status ≥70 for participants≥16 years of age; Lansky performance status of ≥70 for participants\\\u003C16 years of age;\n* Eligible to undergo auto-HSCT;\n* Willing and able to follow the research procedures and conditions, with good compliance;\n* Willing to receive at least the 2 years follow-up;\n* Participant and\u002For legal guardians voluntarily participated in this clinical trial and signed the informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis of composite α thalassemia;\n* Prior receipt of gene therapy or allo-HSCT;\n* Meet the criteria for allo-HSCT and with an identified willing donor with full HLA match;\n* Participants with severe iron overload at the time of screening;\n* Presence of unusual antibody of red blood cell antigens or tested positive for platelet antibody;\n* Known allergy to clinical trial drug (plerixafor or G-CSF or busulfan) or ingredient(DMSO etc.);\n* Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the clinical investigator;\n* Subjects positive with the following etiological tests: human immunodeficiency virus(HIV-1-2),human cytomegalovirus (HCMV-DNA),EB virus（EBV-DNA）,HBV (HBsAg\u002FHBV-DNA positive),HCV antibody (HCV-Ab), Human T-lymphotropic virus antibody (HTLV-Ab), Treponema pallidum antibody (TP-Ab);\n* Uncorrectable coagulation dysfunction or history of severe bleeding disorder;\n* History of major organ damage including:\n\n  1. Liver function test suggest AST or ALT levels \\>3× upper limit of normal（ULN）;\n  2. Total serum bilirubin value\\>2.5×ULN;if combined with Gilbert syndrome, total bilirubin\\>3×ULN and direct bilirubin value\\>2.5×ULN;\n  3. Left ventricular ejection fraction \\\u003C45%;\n  4. Baseline calculated eGFR\\\u003C60mL\u002Fmin\u002F1.73m2;\n  5. Pulmonary function:FEV1\u002FFVC\\\u003C60% and\u002For diffusion capacity of carbon monoxide (DLco) \\\u003C60% of prediction;","ALL","3 Years","35 Years",{"count":80,"type":81},41,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major.",[88],"Transfusion-dependent Beta-Thalassemia",[90,91,92,93],"gene therapy","lentiviral vector","KL003 cell injection","transfusion-dependent β-thalassemia","2025-03-06",{"date":96,"type":97},"2025-03-10","ACTUAL",{"date":99,"type":97},"2024-04-05",{"date":101,"type":81},"2027-05",{"name":5,"class":6},2]