[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CB IL-10\u002FIL-15-CD19-CAR NK","EXPERIMENTAL","All subjects were intravenously administrated with IL-10\u002FIL-15 CD19-CAR NK",[13],"Biological: anti-CD19 IL10\u002FIL15 CAR-NK",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","anti-CD19 IL10\u002FIL15 CAR-NK","Lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19-IL10\u002FIL-15 CAR",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wenbin Qian, Professor","CONTACT","+8613605801032","qianwb@zju.edu.cn",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Hui Liu, Doctor","13819198629","sylen@zju.edu.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"the Second Affiliated Hospital, College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.16142,30.29365,{"lat":44,"lon":43},[47,49],{"name":23,"role":24,"phone":48,"phoneExt":20,"email":26},"13605801032",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100570439","phase-1-clinical-study-of-cord-blood-derived-il-10il-15-cd19-car-nk-in-the-treatment-of-refractoryrelapsed-b-cell-nhl-100570439",false,"NCT06707259","Clinical Study of Cord Blood-derived IL-10\u002FIL-15 CD19-CAR NK in the Treatment of Refractory\u002FRelapsed B-cell NHL","Inclusion Criteria:\n\n1. Volunteer to participate in this study and sign an informed consent form;\n2. Age 18-75 years old, no gender limit;\n3. 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:(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 ； (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) 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; 7, ECOG score 0-2 points;\n7. Sufficient organ function reserve: (1) Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); (2) Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL\u002Fmin; (3) Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; （4）Glomerular filtration rate\\>50Ml\u002Fmin Cardiac ejection fraction (EF) ≥50%; (5) Under natural indoor air environment, basic oxygen saturation\\>92% .\n8. Allow a previous stem cell transplantation.\n9. 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;\n10. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n11. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial.\n12. Two tests for the new coronavirus were negative.\n\nExclusion Criteria:\n\n1. Those who have a history of allergies to any of the ingredients in cell products;\n2. History of other tumors;\n3. Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;\n4. Have received gene therapy in the past 3 months;\n5. Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;\n6. Hepatitis B (HBsAg positive, but HBV-DNA \\\u003C103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including but not limited to people living with HIV;\n7. According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV impaired subjects;\n8. Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);\n9. Subjects with a history of epilepsy or other central nervous system diseases; 10. Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;\n\n11\\. Have any other drugs that target CD19; 12. Women who are breastfeeding and unwilling to stop breastfeeding; 13. Any other situation that the investigator believes may increase the subject's risk or interfere with the test results.","ALL","18 Years","75 Years",{"count":62,"type":63},24,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","To study the safety and effectiveness of cord blood-derived IL-10\u002FIL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma",[69],"B-cell Non Hodgkin Lymphoma","2025-11-17",{"date":72,"type":73},"2025-11-20","ACTUAL",{"date":75,"type":73},"2024-12-01",{"date":77,"type":63},"2027-12-01",{"name":5,"class":6},1]