[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611730":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":19,"responsibleParty":33,"collaborators":19,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":19,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":19,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":19,"overallStatus":54,"whyStopped":19,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":19},{"fullName":5,"class":6},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S101 CD7 CAR-T","EXPERIMENTAL","Autologous CD7-targeting CAR T cells, dosage 2\\*10\\^6\u002Fkg, intravenous injection once",[13],"Biological: Autologous CD7-targeting CAR T cells",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Autologous CD7-targeting CAR T cells",[9],null,[21,25],{"name":22,"affiliation":23,"role":24},"Xiangyu Zhao","Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Weili Zhao","Ruijin Hospital",[29],{"name":22,"role":30,"phone":31,"phoneExt":19,"email":32},"CONTACT","01088325229","Zhao_xy@bjmu.edu.cn",{"type":34,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100611730","phase-2-phase-ii-trial-of-s101-autologous-anti-cd7-car-t-cells-in-patients-with-rr-t-lblall-100611730",false,"NCT07244380","Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R\u002FR T-LBL\u002FALL.","A Phase II Clinical Trial of S101 Autologous CAR-T Cell Injection for the Treatment of CD7-Positive Relapsed or Refractory T-Lymphoblastic Lymphoma\u002FLeukemia (T-LBL\u002FALL).","Inclusion Criteria:\n\n* 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL\u002FALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and\u002For by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\\>12 weeks.\n\nExclusion Criteria:\n\n* 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.","ALL","18 Years","75 Years",{"count":46,"type":47},38,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL\u002FALL.",[53],"T Lymphoblastic Leukemia\u002FLymphoma","NOT_YET_RECRUITING","2025-11-17",{"date":57,"type":58},"2025-11-24","ACTUAL",{"date":60,"type":47},"2025-11-28",{"date":62,"type":47},"2028-06-30",{"name":5,"class":6}]