[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kanglin Biotechnology (Hangzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},41,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Transfusion-dependent Beta-Thalassemia",[30,31,32,33],"gene therapy","lentiviral vector","KL003 cell injection","transfusion-dependent β-thalassemia","RECRUITING","2025-03-06",{"date":37,"type":38},"2025-03-10","ACTUAL",{"date":40,"type":38},"2024-04-05",{"date":42,"type":21},"2027-05",{"name":44,"class":45},"Kanglin Biotechnology (Hangzhou) Co., Ltd.","INDUSTRY",2,""]