[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466095":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":28,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":28,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":28,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":28,"overallStatus":82,"whyStopped":28,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ThisCART19A 2×10^6 cells\u002Fkg for dose level 1","EXPERIMENTAL","Patients will receive 2×10\\^6 cells\u002Fkg of ThisCART19A",[13],"Biological: ThisCART19A",{"label":15,"type":10,"description":16,"interventionNames":17},"ThisCART19A 3×10^6 cells\u002Fkg as dose level 2","Patients will receive 3×10\\^6 cells\u002Fkg of ThisCART19A",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Patients will receive 4×10^6 cells\u002Fkg as dose level 3","Patients will receive 4×10\\^6 cells\u002Fkg of ThisCART19A",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","ThisCART19A","each patient will receive a dose level per body weight(kg) for only once.",[19,9,15],null,[30],{"name":31,"affiliation":32,"role":33},"He Huang, Doctor","First hospital affiliated Zhejiang University","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Ming Ming Zhang, Doctor","CONTACT","13656674208","mingmingzhang@zju.edu.cn",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.16142,30.29365,{"lat":53,"lon":52},[56],{"name":31,"role":37,"phone":57,"phoneExt":28,"email":58},"86-13605714822","hehuangyu@126.com",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":28,"oldOrganization":28},"He Huang","President\u002FProffessor","First Affiliated Hospital of Zhejiang University","100466095","phase-1-assessment-of-safety-and-efficacy-of-thiscart19a-in-adult-patients-with-b-nhl-after-failure-of-autologous-chimeric-antigen-receptor-t--cellcar-t-therapy-100466095",false,"NCT05349266","Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy","Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cells Non-Hodgkin's Lymphoma(B-NHL) After Failure of Autologous CAR-T Therapy","Inclusion Criteria:\n\n* Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.\n* Failing to autologous CAR-T therapy.\n* At least one available lesion to be assessed.\n* Good organ function during screening.\n* Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.\n\nExclusion Criteria:\n\n* Allergic to preconditioning measures.\n* Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical\u002Fbreast cancer can be recruited.\n* Uncontrollable bacterial, fungal and viral infection during screening.\n* Patients had pulmonary embolism within 3 months prior to enrollment.\n* Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.\n* Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \\\u003C 2000 IU\u002FmL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment.\n* Had big lesion(single lesion diameter ≥10 cm).\n* Bone marrow involvement≥5%.\n* Receive allogeneic hematopoietic stem cell transplantation less than 100 days.\n* Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.\n* Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live\u002Fnon-live adjuvant vaccinations allowed to be included) .\n* Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.\n* Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.","ALL","18 Years","75 Years",{"count":74,"type":75},16,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.",[81],"Non-Hodgkin's Lymphoma","UNKNOWN","2022-04-21",{"date":85,"type":86},"2022-04-27","ACTUAL",{"date":88,"type":86},"2022-03-18",{"date":90,"type":75},"2024-04-30",{"name":5,"class":6},1]