[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644618":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":33,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":33,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":33,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":85,"whyStopped":33,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Cohort 1: 0.3 × 10^6 Cells\u002Fkg","EXPERIMENTAL","Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.3 × 10\\^6 cells\u002Fkg.",[13],"Biological: GoFast CD19 CAR T Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Cohort 2: 0.6 × 10^6 Cells\u002Fkg","Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.6 × 10\\^6 cells\u002Fkg.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Cohort 3: 1.2 × 10^6 Cells\u002Fkg","Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 1.2 × 10\\^6 cells\u002Fkg.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","GoFast CD19 CAR T Cells","GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg\u002Fm2 and cyclophosphamide 300 mg\u002Fm2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10\\^6 cells\u002Fkg, 0.6 × 10\\^6 cells\u002Fkg, or 1.2 × 10\\^6 cells\u002Fkg.",[9,15,19],[29,30,31,32],"CD19 CAR T-Cell Therapy","Autologous CD19 CAR T Cells","GoFast CD19CAR-T","CD19-Targeted CAR T Cells",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Chunji Gao, PhD","CONTACT","+86-13911536256","gaochunji301@163.com",[41],{"facility":5,"status":33,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Beijing","Beijing Municipality","100071","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Chunji Gao","Principal Investigator","100644618","early-phase-1-gofast-car-t-cell-therapy-for-recurrent-refractory-b-cell-lymphoma-100644618",false,"NCT07670260","GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma","Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically or cytologically confirmed primary refractory or relapsed\u002Fprogressive large B-cell lymphoma.\n* Expected survival of more than 3 months.\n* CD19-positive B-cell lymphoma confirmed by flow cytometry or immunohistochemistry.\n* ECOG performance status of 0 to 2 or KPS score greater than 80.\n* Adequate venous access for leukapheresis or peripheral blood collection, with no contraindication to blood cell separation.\n* White blood cell count ≥ 1 × 10\\^9\u002FL and lymphocyte count ≥ 0.3 × 10\\^9\u002FL.\n* INR \\\u003C 1.7 or prothrombin time prolonged by less than 4 seconds above the normal value.\n* ALT and AST ≤ 2.5 × upper limit of normal.\n* Total bilirubin ≤ 2.0 mg\u002FdL, equivalent to 34.2 μmol\u002FL.\n* Able to understand and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Active hepatitis B virus or hepatitis C virus infection.\n* HIV\u002FAIDS infection.\n* Any uncontrolled active infection.\n* Systemic corticosteroid use within 2 weeks before signing informed consent, except inhaled corticosteroids.\n* Active cardiac disease requiring treatment or poorly controlled hypertension.\n* Unstable or active ulcer disease or gastrointestinal bleeding.\n* History of organ transplantation or currently awaiting organ transplantation.\n* Central nervous system involvement by lymphoma.\n* Current participation in another clinical trial.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical study.","ALL","18 Years",{"count":69,"type":70},9,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","This is an investigator-initiated, prospective, open-label exploratory clinical study designed to evaluate the safety and preliminary efficacy of GoFast CD19 CAR T-cell therapy in adult patients with recurrent or refractory B-cell lymphoma. Eligible patients will undergo screening, baseline assessment, peripheral blood or leukapheresis collection, lymphodepleting chemotherapy, and intravenous infusion of GoFast CD19 CAR T cells. The study plans to enroll 9 participants using a sequential dose-escalation design. The primary outcome is objective response rate, and secondary outcomes include complete remission rate, overall survival, progression-related survival outcomes, duration of response, MRD negativity, and adverse events.",[76],"Relapsed or Refractory Large B-cell Lymphoma",[78,79,80,81,82,83,84],"CD19","CAR T-Cell Therapy","GoFast Platform","Large B-Cell Lymphoma","Relapsed or Refractory Lymphoma","Dose Escalation","Autologous CAR T Cells","NOT_YET_RECRUITING","2026-06-25",{"date":88,"type":89},"2026-06-26","ACTUAL",{"date":91,"type":70},"2026-06-30",{"date":93,"type":70},"2028-06-30",{"name":5,"class":6},1]