[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489938":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":19,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":19,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Ningbo No. 1 Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T combined with anti-PD1 treatment group","EXPERIMENTAL","CD19-7×19 CAR-T combined with Tislelizumab",[13],"Combination Product: CD19-7×19 CAR-T combined with Tislelizumab",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","Participants will receive 2×106\u002FKg CD19-7×19 CAR-T cells infusion and Tislelizumab 200mg every 21 days for 6 cycle on the 31st day after CAR-T infusion.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Lixia Sheng, doctor","CONTACT","86-574-87085596","slx800408@163.com",[27,46],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":36,"coordinates":37},"Point",[38,39],120.16142,30.29365,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Wenbin Qian, Doctor","86-571-87581969","qianwb@zju.edu.cn",{"facility":47,"status":29,"city":48,"state":31,"zip":49,"country":33,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Ningbo First Hospital","Ningbo","315010",{"type":36,"coordinates":51},[52,53],121.54945,29.87819,{"lat":53,"lon":52},[56],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":58,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[60],{"name":61,"class":6},"Zhejiang University","100489938","phase-1-cd19-car-t-expressing-il-7-and-ccl19-combined-with-anti-pd1-in-rr-dlbcl-100489938",false,"NCT05659628","CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL","Phase Ib Clinical Study of CD19 CAR-T Expressing IL-7 and CCL19 Combined With Tislelizumab in the Treatment of Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18, upper limit 75, male or female;\n2. ECOG score 0-3;\n3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) \\[diagnostic criteria according to WHO 2008\\];\n4. CD19 positive (immunohistochemistry or flow cytometry).\n5. DLBCL refractory or relapse is defined as: complete remission is not achieved after 2-line treatment; let What disease progress occurs during treatment, or the disease stability time is equal to or less than 6 months; Or autologous hematopoietic stem Disease progression or recurrence within 12 months after cell transplantation;\n6. Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody) and anthracyclines;\n7. At least one measurable lesion is required, and any lymph node lesion with a length greater than 1.5cm or extranodal lesion is required If any length diameter is greater than 1.0 cm, the lesions on PET-CT scan have uptake (SUV is larger than liver blood pool);\n8. Absolute value of peripheral blood neutrophils ≥ 1000\u002F μ l. Platelets ≥ 45000\u002F μ l\n9. Heart, liver and kidney functions: creatinine \\\u003C 1.5mg\u002FdL; ALT\u002FAST Less than 2.5 times of normal upper limit; Total bilirubin \\\u003C 1.5mg\u002FdL; Cardiac ejection fraction (EF) ≥ 50%;\n10. Have sufficient understanding and voluntarily sign the informed consent form;\n11. People with fertility must be willing to use contraceptive methods;\n12. According to the judgment of the researcher, the expected survival period is at least 4 months;\n13. Willing to follow the visit schedule, administration plan, laboratory inspection and other test steps.\n\nExclusion Criteria:\n\n1. Have a history of other tumors;\n2. Autologous hematopoietic stem cell transplantation was performed within 6 weeks;\n3. Any target CAR-T treatment was performed within 3 months before this CAR-T treatment;\n4. Previously used any commercially available PD-1 monoclonal antibody;\n5. Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection;\n6. Active autoimmune diseases;\n7. Uncontrollable active bacterial and fungal infections;\n8. HIV infection and syphilis infection; Active hepatitis B or hepatitis C: hepatitis B: HBV-DNA ≥ 1000 IU\u002FmL; Hepatitis C: HCV RNA is positive and liver function is abnormal.\n9. Known central nervous system lymphoma.","ALL","18 Years","75 Years",{"count":73,"type":74},24,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question\\[s\\] it aims to answer are:\n\nquestion 1：What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.\n\nquestion 2：What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma.\n\nParticipants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.",[80],"Diffuse Large B-cell Lymphoma","2022-12-12",{"date":83,"type":84},"2022-12-21","ACTUAL",{"date":86,"type":74},"2022-12",{"date":88,"type":74},"2026-12",{"name":5,"class":6},2]