[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551805":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":55,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":19,"overallStatus":38,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19-CAR-NK\u002FT","EXPERIMENTAL","All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10\\^6\u002Fkg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10\\^6\u002Fkg",[13],"Biological: CD19-CAR-NK\u002FT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Wenbin Wenbin, Professor","Zhejiang University","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Wenbin Qian, Professor","CONTACT","+8613605801032","qianwb@zju.edu.cn",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Hui Liu, Professor","13819198629","sylen@zju.edu.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"the Second Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":45,"coordinates":46},"Point",[47,48],120.16142,30.29365,{"lat":48,"lon":47},[51,53],{"name":27,"role":28,"phone":52,"phoneExt":19,"email":30},"13605801032",{"name":54,"role":28,"phone":19,"phoneExt":19,"email":34},"Hui Liu, Doctor",{"type":56,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100551805","phase-1-sequential-treatment-of-cd19-carnk-and-7x19-car-t-in-rr-b-cell-lymphoma-100551805",false,"NCT06464861","Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R\u002FR B Cell Lymphoma","Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed\u002FRefractory B Cell Lymphoma","CD19-CARNK\u002FT","Inclusion Criteria:\n\n1. Age 18-75 years old, no gender limit;\n2. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:\n\n   1. Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；\n   2. Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;\n   3. Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;\n3. Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;\n4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;\n5. The expected survival period is ≥12 weeks;\n6. The puncture section of the tumor tissue was positive for CD19 expression;\n7. ECOG score 0-2 points;\n8. Sufficient organ function reserve:\n\n   1. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);\n   2. Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL\u002Fmin;\n   3. Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;\n   4. Glomerular filtration rate\\>50Ml\u002Fmin\n   5. Cardiac ejection fraction (EF) ≥50%;\n   6. Under natural indoor air environment, basic oxygen saturation\\>92%\n9. Allow a previous stem cell transplantation\n10. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;\n11. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n12. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial\n13. Two tests for the new coronavirus or swine flu virus are negative.\n\nExclusion Criteria:\n\n1. Allergic to any of the components of cell products;\n2. History of other tumors;\n3. Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;\n4. Had received gene therapy within the past 3 months;\n5. Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;\n6. Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \\< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;\n7. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\\'s cardiac function grading criteria;\n8. Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);\n9. Subjects with a history of epilepsy or other central nervous system disorders;\n10. Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;\n11. Lactating women who are unwilling to stop breastfeeding;\n12. Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.","ALL","18 Years","75 Years",{"count":69,"type":70},52,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse \u002F refractory B cell lymphoma",[76,77,78],"Primary Mediastinal B-cell Lymphoma (PMBCL)","Mantle Cell Lymphoma (MCL)","Diffuse Large B Cell Lymphoma( DLBCL)","2025-02-04",{"date":81,"type":82},"2025-02-07","ACTUAL",{"date":84,"type":82},"2024-06-20",{"date":86,"type":70},"2027-06-30",{"name":5,"class":6},1]