[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551604":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":53,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":31,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":31,"enrollmentInfo":69,"targetDuration":31,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single arm","EXPERIMENTAL","Single arm open labelled phase 2 study",[13],"Drug: CUCART19",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CUCART19","anti-CD19 chimeric antigen receptor modified T-cell (CAR-T)",[9],[21],"anti-CD19 CAR-T",[23],{"name":24,"affiliation":25,"role":26},"Chi Kong Li, MD","Chinese University of Hong Kong","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","852-35051019",null,"ckli@cuhk.edu.hk",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Yvonne Chu, MD","yvonnechu@cuhk.edu.hk",[37],{"facility":38,"status":39,"city":40,"state":31,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Prince of Wales Hospital","RECRUITING","Hong Kong","China","CN",{"type":44,"coordinates":45},"Point",[46,47],114.17469,22.27832,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":31,"email":31},"Chi-Kong Li, MD","852-3505-1019",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Chi Kong Li","Research Professor",[58],{"name":59,"class":6},"Hong Kong Children's Hospital","100551604","phase-2-anti-cd19-chimeric-antigen-receptor-modified-t-cell-car-t-therapy-for-treatment-of-b-cell-hematological-malignancies-100551604",false,"NCT06462248","Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies","A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies","Inclusion Criteria:\n\nAcute Lymphoblastic Leukaemia\n\n* Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease\n* ECOG performance score of ≤2 if \\>16 years old, or Lansky performance score of \\>50 if ≤16 years old at screening\n* Post allogeneic stem cell transplant patients with B cell ALL will be eligible \\> 3 months after transplant and off immunosuppression for at least 1 month.\n* Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,\n* For women of childbearing potential, a negative pregnancy test prior to apheresis\n\nB-cell lymphoma\n\n* Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification\n* Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse\n* Received at least two prior treatment which must include at least one intensive systemic therapy.\n* Disease progression or relapsed disease within 12 months after autologous stem cell transplant\n* ECOG performance score of ≤2 if \\>16 years old, or Lansky performance score of \\>50 if ≤16 years old at screening\n* Has sufficient organ function to tolerate treatment with CAR-T cell therapy\n* For women of childbearing potential, a negative pregnancy test prior to apheresis\n\nExclusion criteria of both cohorts\n\n* Patients with active infection\n* Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression\n* Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)\n* Patients who are positive for HBsAg, HCV RNA positive or with HIV infection\n* Pulmonary function: Grade 1 dyspnea and pulse oxygenation \\> 91% on room air\n* Cardiac function: Fractional shortening \\\u003C28% or left ventricular ejection fraction \\\u003C45% by echocardiography.\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: Patients with a serum bilirubin \\>3 times upper limit of normal or an AST or ALT \\> 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator\n* Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.","ALL","1 Year",{"count":70,"type":71},20,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","CAR-T therapy is now available as a commercial product for treatment of relapsed \u002Frefractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.",[77,78],"Lymphoma, Nonhodgkin","Leukemia, Lymphocytic",[80,81],"relapsed leukemia","relapsed B-cell lymphoma","2024-06-14",{"date":84,"type":85},"2024-06-17","ACTUAL",{"date":87,"type":85},"2024-06-01",{"date":89,"type":71},"2027-12-31",{"name":55,"class":6},1]