[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489046":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":37,"responsibleParty":61,"collaborators":63,"id":66,"slug":20,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":88,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","CD19-directed CAR T-cell therapy for relapsed\u002Frefractory B-lineage leukaemia\u002Flymphoma.",[13],"Biological: Anti-CD19 CAR T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Anti-CD19 CAR T-cells","A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Shui Yen Soh, MD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Aloysius Ho, MD","Singapore General Hospital",[29,33],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","+65 6394 1045","soh.shui.yen@singhealth.com.sg",{"name":34,"role":30,"phone":35,"phoneExt":20,"email":36},"Germaine Liew, BS","+65 6394 5025","germaine.liew.shimin@singhealth.com.sg",[38,52],{"facility":27,"status":39,"city":40,"state":20,"zip":41,"country":40,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Singapore","169608",{"type":43,"coordinates":44},"Point",[45,46],103.85007,1.28967,{"lat":46,"lon":45},[49,50],{"name":26,"role":30,"phone":20,"phoneExt":20,"email":20},{"name":51,"role":24,"phone":20,"phoneExt":20,"email":20},"Aloysius Ho",{"facility":5,"status":39,"city":40,"state":20,"zip":53,"country":40,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"229899",{"type":43,"coordinates":55},[45,46],{"lat":46,"lon":45},[58,60],{"name":59,"role":30,"phone":31,"phoneExt":20,"email":32},"Shui Yen Soh",{"name":59,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":62,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[64],{"name":27,"class":65},"OTHER","100489046",false,"NCT05648019","CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002FRefractory B-Lineage Leukaemia \u002F Lymphoma - A Feasibility Protocol","Inclusion Criteria:\n\n1. Eligible disease conditions:\n\n   1. Relapsed or refractory B-cell ALL (all must be satisfied)\n\n      * Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.\n      * Relapsed or refractory or ineligible for HSCT\n      * For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry\n   2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n2. Age at screening:\n\n   1. \\\u003C 18 years (paediatric group); or\n   2. ≥ 18 years (adult group)\n3. Adequate organ functions:\n4. Life expectancy more than 12 weeks.\n5. Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening.\n6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded:\n\n* B-ALL with isolated extramedullary disease relapse\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.\n* Patients with Burkitt's lymphoma\u002Fleukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \\[sIg positive and kappa or lambda restricted positivity\\] ALL, with FAB L3 morphology and \u002For a MYC translocation)\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening\n* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)\n* Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.\n* Patient has an investigational medicinal product within the last 30 days prior to screening.\n* Pregnant or nursing women.\n* Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.\n\nThe following are not strictly exclusion criteria but must be discussed with PI\u002FSite-PI:\n\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n* Treatment with any prior gene therapy product\n* Has had treatment with any prior anti-CD19\u002Fanti-CD3 therapy, or any other anti-CD19 therapy","ALL","0 Years","70 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed\u002F refractory B-lineage leukaemia\u002F lymphoma.",[82,83,84,85,86,87],"Lymphoblastic Leukemia","Lymphoblastic Leukemia in Children","Lymphoblastic Leukemia, Acute Adult","B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","CAR",[89,90,91,92],"CAR T-cell therapy","Relapse\u002FRefractory","B-ALL","B-Lineage Lymphoma","2023-03-07",{"date":95,"type":96},"2023-03-09","ACTUAL",{"date":98,"type":96},"2022-03-15",{"date":100,"type":76},"2026-12",{"name":5,"class":6},2]