[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564757":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":21,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":21,"maxAge":21,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Aplastic Anemia",[13,14],"Drug: CD7 CAR-T cells injection","Other: Allogeneic hematopoietic stem cell transplantation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","CD7 CAR-T cells injection","CD7 CAR T cells treat patients with severe aplastic anemia",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Allogeneic hematopoietic stem cell transplantation","In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia",[9],[27],{"name":28,"affiliation":5,"role":29},"He Huang, MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"He Z Huang, MD","CONTACT","13605714822","hehuangyu@126.com",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Yongxian Hu, MD","86-15957162012","huyongxian2000@aliyun.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":21,"geoPoint":21,"contacts":49},"The First Affiliated Hospital of Zhejiang University School of Medicine","RECRUITING","Hanzhou","Zhejiang","310003","China","CN",[50,52],{"name":28,"role":33,"phone":51,"phoneExt":21,"email":35},"0571-87233772",{"name":37,"role":33,"phone":51,"phoneExt":21,"email":39},{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"He Huang","Clinical Professor",[57],{"name":58,"class":59},"Yake Biotechnology Ltd.","INDUSTRY","100564757","early-phase-1-cd7-car-t-bridging-to-allohsct-for-severe-aplastic-anemia-100564757",false,"NCT06633328","CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia","Clinical Study on the Safety and Efficacy of Donor Derived CD7 CAR-T Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the for Patients With Severe Aplastic Anemia","Inclusion Criteria:\n\n* Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation \\\u003C 25%, or 25%-50% but residual hematopoietic cells \\\u003C 30%；2. With pancytopenia (at least two of the following peripheral blood parameters) : (1) absolute neutrophil \\\u003C0.5×10\\^9\u002FL; (2) Platelet count\\\u003C 20×10\\^9\u002FL; (3) The absolute value of reticulocytes \\\u003C20×109\u002FL;\n* Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;\n* Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;\n* creatinine clearance \\> 60ml\u002Fmin; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. If there is liver invasion, serum erythrambirubin ≤ 3 times the upper limit of normal, and serum ALT and AST are both ≤ 5 times the upper limit of the normal range;\n* Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* Estimated survival time ≥ 3 months;\n* ECOG performance status 0 to 1;\n* Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is not known and has unknown risks);\n* Those who voluntarily participated in this trial and provided informed consent;\n\nExclusion Criteria:\n\n* Allergy to pre-treatment measures；\n* Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；\n* History of epilepsy or other central nervous system disorders；\n* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* Less than 100 days after allogeneic hematopoietic stem cell transplantation；\n* Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；\n* The proiferation rate is less than 5 times response to CD3\u002FCD28 co-stimulation signal;\n* Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;\n* Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.","ALL",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia",[11],[77,78],"allo-HSCT","CD7 CAR-T","2024-10-08",{"date":81,"type":82},"2024-10-09","ACTUAL",{"date":84,"type":70},"2024-10-20",{"date":86,"type":70},"2027-10-20",{"name":5,"class":6},1]