[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581436":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":38,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":38,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":38,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":42,"whyStopped":38,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Shanxi Bethune Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group1","EXPERIMENTAL","Subjects received a single low-dose CD30 CAR-T therapy(1\\*10\\^6\u002Fkg CAR+T cells)",[13],"Drug: chimeric antigen receptor gene modified T cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Group2","Subjects received a single low-dose CD30 CAR-T therapy(2\\*10\\^6\u002Fkg CAR+T cells)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group3","Subjects received a single low-dose CD30 CAR-T therapy(5\\*10\\^6\u002Fkg CAR+T cells)",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","chimeric antigen receptor gene modified T cells","The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL\u002Fmin, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\\~30 mL normal saline.",[9,15,19],[29],"CAR-T",[31],{"name":32,"affiliation":5,"role":33},"jia wei","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","13986102084",null,"iawei@tjh.tjmu.edu.cn",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":38,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Taiyuan","Shangxi","China","CN",{"type":48,"coordinates":49},"Point",[50,51],112.56028,37.86944,{"lat":51,"lon":50},[54],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":55},"jiawei@tjh.tjmu.edu.cn",{"type":57,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100581436","cd30-car-t-in-the-treatment-of-cd30-positive-relapsedrefractory-lymphoma-100581436",false,"NCT06850285","CD30 CAR-T in the Treatment of CD30 Positive Relapsed\u002FRefractory Lymphoma","Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed\u002FRefractory Lymphoma","Inclusion Criteria:\n\n* Age≥15 years and ≤80years，female and male；\n* CD30+ lymphocyte malignancies;\n* CD30 expression \\>10% by immunohistochemistry；\n* At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;\n* Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;\n* Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;\n* The estimated survival time ≥3 months;\n* ECOG performance status 0-2，KPS\\>60%;\n* Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\\\u003C34 μmol\u002FL；creatinine clearance rate\\>30 mL\u002Fmin；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；\n* ALC ≥0.5×109\u002FL，PLT\\>30×109\u002FL，Hb\\>80 g\u002FL and subjects had apheresis venous access and no contraindications for blood cell separation;\n* MRI showed no central involvement of lymphoma;\n* Patients with fertility must be willing to be able to use reliable contraceptive measures ;\n* The subject or legal guardian can understand and voluntarily sign the written informed consent.\n\nExclusion Criteria:\n\n* Lymphoma-associated hemophagic cell syndrome;\n* Pregnant or lactating women, and women who have a pregnancy plan within six months;\n* Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ\u002FⅡ and anti-TP positive（Hepatitis B DNA test is negative except）;\n* Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;\n* Received Anti-CD30 Ab therapy within 4 weeks before enrollment;\n* Unresolved \\> Grade 1 non-hematologic toxicity associated with any prior treatments;\n* Active uncontrolled bleeding or a known bleeding diathesis;\n* Autologous hematopoietic stem cell transplantation was performed within 6 weeks;\n* Uncontrollable active bacterial or fungal infection；\n* Known allergy to the study drug and its components;\n* Suffer from active autoimmune diseases that require systemic treatment ;\n* Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;\n* Participated in other clinical studies within 1 months prior to this study;\n* History of allogeneic hematopoietic stem cell transplantation;\n* patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.","ALL","15 Years","80 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73],"NA","The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r\u002Fr CD30+ lymphoma. Plan to recruit 15 subjects with r\u002Fr CD30+ lymphoma。",[76],"Lymphoma, B-Cell",[78],"CD30 CAR-T; lymphoma;","2025-02-23",{"date":81,"type":82},"2025-02-27","ACTUAL",{"date":84,"type":70},"2025-09-05",{"date":86,"type":70},"2028-06-01",{"name":5,"class":6},1]