[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-rr-lbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-rr-lbcl":27},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100634357","phase-2-car-t-combined-with-asct-in-the-treatment-of-relapsedrefractory-large-b-cell-lymphoma-with-high-risk-factors-100634357",false,"NCT07538635","CAR-T Combined With ASCT in the Treatment of Relapsed\u002FRefractory Large B-cell Lymphoma With High-risk Factors.","A Single-arm, Single-center, Open-label Clinical Study on the Efficacy and Safety of CAR-T Combined With ASCT in the Treatment of Relapsed\u002FRefractory Large B-cell Lymphoma With High-risk Factors.","CAR-T+ASCT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)\n3. Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline\n4. Meet one of the following clinical high-risk factors or molecular biological high-risk factors:\n\n   1. Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression\n   2. Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement\n5. ECOG 0 to 2\n6. Eligible for high-dose chemotherapy\u002Fautologous hematopoietic stem cell transplantation (HDCT\u002FASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy\n7. Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg\u002FdL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL\u002Fmin\n8. Left ventricular ejection fraction (LVEF) ≥ 40%\n9. Life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n1. Patients who have previously received any CD19-targeted therapy\n2. Patients with CD19 negativity confirmed by immunohistochemistry (IHC)\n3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities\n4. Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases\n5. History of human immunodeficiency virus (HIV) infection\n6. Pregnant or lactating patients","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed\u002Frefractory large B-cell lymphoma with high-risk factors.",[27],"High-risk R\u002FR LBCL",[29,30,31,32],"CART","ASCT","R\u002FR LBCL","high-risk factors","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-13","ACTUAL",{"date":39,"type":37},"2026-04-20",{"date":41,"type":21},"2028-02-29",{"name":43,"class":44},"Zhejiang Cancer Hospital","OTHER"]