[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma-nonhodgkin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma-nonhodgkin":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Lymphoma, Nonhodgkin","Leukemia, Lymphocytic",[29,30],"relapsed leukemia","relapsed B-cell lymphoma","RECRUITING","2024-06-14",{"date":34,"type":35},"2024-06-17","ACTUAL",{"date":37,"type":35},"2024-06-01",{"date":39,"type":20},"2027-12-31",{"name":41,"class":42},"Chi Kong Li","OTHER"]