[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611730":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":33,"centralContacts":41,"locations":13,"responsibleParty":46,"collaborators":13,"id":48,"slug":13,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":13,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":13,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":13,"overallStatus":66,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":13},{"fullName":5,"class":6},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate after S101 infusion [Effectiveness]","Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion.","3 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This study is a Phase II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S101 in patients with CD7-positive relapsed or refractory T-lymphoblastic lymphoma\u002Fleukemia (T-LBL\u002FALL).\n\nThe primary objective： To evaluate the efficacy of S101 in patients with relapsed or refractory T-LBL\u002FALL.\n\nThe secondary objectives： To further characterize the efficacy, safety, pharmacokinetics and pharmacodynamics of S101 in this patient population.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"S101 CD7 CAR-T","EXPERIMENTAL","Autologous CD7-targeting CAR T cells, dosage 2\\*10\\^6\u002Fkg, intravenous injection once",[27],"Biological: Autologous CD7-targeting CAR T cells",[29],{"type":30,"name":31,"description":25,"armGroupLabels":32,"otherNames":13},"BIOLOGICAL","Autologous CD7-targeting CAR T cells",[23],[34,38],{"name":35,"affiliation":36,"role":37},"Xiangyu Zhao","Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Weili Zhao","Ruijin Hospital",[42],{"name":35,"role":43,"phone":44,"phoneExt":13,"email":45},"CONTACT","01088325229","Zhao_xy@bjmu.edu.cn",{"type":47,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":58,"type":59},38,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL\u002FALL.",[65],"T Lymphoblastic Leukemia\u002FLymphoma","NOT_YET_RECRUITING","2025-11-17",{"date":69,"type":70},"2025-11-24","ACTUAL",{"date":72,"type":59},"2025-11-28",{"date":74,"type":59},"2028-06-30",{"name":5,"class":6}]