[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589020":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":32,"overallOfficials":18,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":62,"id":66,"slug":18,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":18,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":18,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Grit Biotechnology","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events per CTCAE 5.0","To characterize the safety profile of GT719 in patients with recurrent\u002Frefractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0","From infusion to the end of the treatment at 12 months",[14],{"measure":15,"description":16,"timeFrame":17},"Objective response rate","To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator","28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"GT719 Injection treatment group","EXPERIMENTAL","GT719 Injection",[31],"Biological: GT719 Injection",[33],{"type":34,"name":29,"description":29,"armGroupLabels":35,"otherNames":18},"BIOLOGICAL",[27],[37],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Dehui Zou","CONTACT","+8613602100955","zoudehui@ihcams.ac.cn",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":18,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},[57,58],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},{"name":38,"role":59,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[63],{"name":64,"class":65},"Institute of Hematology & Blood Diseases Hospital, China","OTHER","100589020",false,"NCT06948981","GT719 Injection for the Treatment of Recurrent\u002FRefractory CD19 Positive Adult B-cell Malignancies","A Single-arm, Open-label, Phase I\u002FII Clinical Study of GT719 Injection for Recurrent\u002FRefractory CD19 Positive Adult B-cell Malignancies","Inclusion Criteria:\n\n1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.\n\n   \\-\n2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.\n\n   \\-\n3. CD19 positivity confirmed by flow cytometry and\u002For histopathology.\n\nExclusion Criteria:\n\n1. Primary immunodeficiency.\n\n   \\-\n2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.\n\n   \\-\n3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;","ALL","18 Years","75 Years",{"count":76,"type":77},46,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This study is a prospective single-arm open-labled phase I\u002FII clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed\u002Frefractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.",[84],"Hematological Malignancy (Leukemia- Lymphoma)","2025-09-10",{"date":87,"type":88},"2025-09-16","ACTUAL",{"date":90,"type":88},"2025-04-18",{"date":92,"type":77},"2028-04-17",{"name":5,"class":6},1]