[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkins-lymphoma-relapsed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkins-lymphoma-relapsed":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100499182","early-phase-1-safety-and-feasibility-of-cd19-car-t-cells-using-clinimacs-prodigy-for-relapsedrefractory-cd19-positive-all-and-nhl-100499182",false,"NCT05779930","Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed\u002FRefractory CD19 Positive ALL and NHL","Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed\u002FRefractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Eligible Diseases:\n\nRelapsed or refractory pediatric B-Cell ALL as defined by at least one of the following criteria:\n\n* Second or greater relapse OR\n* Any relapse after allogeneic SCT OR\n* Not achieving a CR after 2 cycles of standard chemotherapy regimen (including persistent MRD positive disease) OR\n* Not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia (including persistent MRD positive disease) OR\n* Patients with Philadelphia chromosome positive (Ph+) ALL who are intolerant or have failed 3 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated OR\n* Patients who meet accepted indications for allogeneic HSCT for pediatric ALL but are deemed unfit for HSCT by their treating physician are eligible for this study. This includes high risk patients in first relapse.\n\nPatients with relapsed or refractory pediatric B cell non-Hodgkin's Lymphoma as defined by:\n\n* Refractory to second-line or later lines of standard chemotherapy OR\n* Patients with residual disease after primary therapy and not eligible for autologous SCT OR\n* Any relapse after previous allogeneic or autologous SCT OR\n* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT\n\nNote: patients with a history of blinatumomab therapy are eligible for this study.\n\nInclusion Criteria:\n\n* For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.\n* Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.\n* Meets criteria for non-hematopoietic organ function:\n\n  * Renal function: Estimated glomerular filtration rate ≥60 mL\u002Fmin x appropriate estimation of patient's body surface area m2\u002F1.73m2 using the modified Schwartz formula for pediatric patients and Crockcoft Gault formula for adults.\n  * Liver function: Total bilirubin ≤ 2 mg\u002Fdl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and ALT and AST ≤ 5 x ULN for age (unless related to leukemic involvement)\n  * Cardiac function: left ventricular ejection fraction ≥40%\n  * Pulmonary function: minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\>91% on room air\n* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator.\n* Signed consent by parent\u002Fguardian and assent if appropriate for subjects \\\u003C 18 years of age. Signed consent by patient\u002Fsubject if ≥18 years of age.\n\nExclusion Criteria:\n\n* Acute\u002Fongoing neurologic toxicity \\> Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable\u002Fimproving over the past 1 months.\n* Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.\n* Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment\n* Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening\n* Pregnant or nursing (lactating) women.\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* HIV positive test within 8 weeks of screening\n* Allogeneic HSCT within 3 months of enrollment\n* Any prior CD19 CAR T cell therapy","ALL","30 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.\n\nPatients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.",[26,27,28,29,30,31],"Acute Lymphoblastic Leukemia, in Relapse","Non-Hodgkin's Lymphoma, Relapsed","Non-Hodgkin's Lymphoma Refractory","Acute Lymphoblastic Leukemia With Failed Remission","B-cell Non Hodgkin Lymphoma","B Cell Leukemia",[16,33,34],"NHL","CD19 CAR T cells","NOT_YET_RECRUITING","2025-08-13",{"date":38,"type":39},"2025-08-15","ACTUAL",{"date":41,"type":20},"2025-10",{"date":43,"type":20},"2035-12",{"name":45,"class":46},"Nationwide Children's Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":47},"100443427","phase-1-cart19-cells-effects-in-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-and-non-hodgkins-lymphoma-100443427","NCT05054257","CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed\u002Frefractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.","UHKT-CAR19-01","Inclusion Criteria:\n\n1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:\n\n   1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR\n   2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR\n   3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).\n2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age ≥18 years and ≤ 80 yearss.\n4. Patient able to understand and sign informed consent.\n5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n\nGeneral Exclusion Criteria:\n\n1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).\n2. Autologous or allogeneic HCT in 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 6 weeks.\n5. Parenchymal central nervous system involvement.\n6. Respiratory insufficiency (need for oxygen therapy).\n7. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4times normal upper limit.\n8. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n9. Heart failure with EF \\\u003C 30% by echocardiography.\n10. Presence of active grade 3-4 acute GvHD.\n11. Serious uncontrolled neurological comorbidity.\n12. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n13. Women: pregnancy or breast-feeding.\n14. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    * female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    * male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.\n\nExclusion criteria to Procurement of IMP manufacture starting material\n\n1. Severe uncontrolled active infection.\n2. Positive test results for HIV1\u002F2, Hepatitis B\u002FC and lues.\n3. Concurrent or recent prior therapies before apheresis:\n\n   * Autologous or allogeneic hematopoietic cell transplantation within 12 weeks.\n   * Clofarabine, Fludarabine, Alemtuzumab within 8 weeks.\n   * Donor lymphocyte infusions within 4 weeks.\n   * Pegylated asparaginase within 4 weeks.\n   * Maintenance chemotherapy within 2 weeks.\n   * Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks.\n   * Vincristine within 2 weeks.\n   * Intrathecal methotrexate within 1 week.\n   * Granulocyte Colony Stimulating Factor (G-CSF) within 5 days.\n   * Therapeutic dose of corticosteroids within 3 days.\n   * Short-acting cytostatics within 3 days\n\nExclusion criteria to IMP administration\n\n1. Severe, uncontrolled active infections.\n2. Life expectancy \\\u003C 6 weeks.\n3. Parenchymal central nervous system involvement\n4. Respiratory insufficiency (need for oxygen therapy).\n5. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 4times normal upper limit.\n6. Acute kidney injury with serum creatinine \\> 180 µg\u002FL, oliguria or need for acute dialysis.\n7. Heart failure with Ejection Fraction (EF) \\\u003C 30% by echocardiography.\n8. Presence of active grade 3 - 4 acute GvHD\n9. Serious uncontrolled neurological comorbidity.","18 Years","80 Years",{"count":59,"type":20},10,[61],"PHASE1","Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed \u002F Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.",[64,28,27],"Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia",[66,16,67,68,69,70,71,72],"B Cell","Relapsed or Refractory","B-NHL","Leukemia","Chimeric antigen receptor","CAR","CAR T cell","RECRUITING","2025-01-03",{"date":76,"type":39},"2025-01-06",{"date":78,"type":39},"2021-06-02",{"date":80,"type":20},"2025-12-12",{"name":82,"class":46},"Institute of Hematology and Blood Transfusion, Czech Republic",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":47},"100408853","early-phase-1-car-t-cells-combined-with-dasatinib-for-patients-with-relapsed-andor-refractory-b-cell-hematological-malignancies-100408853","NCT04603872","CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Hematological Malignancies","Clinical Trial for the Safety and Efficacy of CD19\u002FBCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);\n2. Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):\n\n   1. CR not achieved after standardized chemotherapy;\n   2. CR achieved following the first induction, but CR duration is less than 12 months;\n   3. Ineffectively after first or multiple remedial treatments;\n   4. 2 or more relapses;\n   5. Relapse after hematopoietic stem cell transplantation;\n   6. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;\n3. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol\u002FL;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 12 weeks;\n7. ECOG performance status 0 to 2;\n8. Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.\n9. Patients volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine \\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts, or bilirubin \\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.","70 Years",{"count":92,"type":20},120,[23],"A Study of CD19\u002FBCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.",[96,97,26,98,27,28],"Multiple Myeloma in Relapse","Multiple Myeloma, Refractory","Acute Lymphocytic Leukaemia Refractory",[100,101,102,103,104],"Acute Lymphoblastic Leukemia","Non-Hodgkin's Lymphoma","Multiple Myeloma","CAR T-cell therapy","Dasatinib","2020-10-27",{"date":107,"type":39},"2020-10-28",{"date":109,"type":20},"2020-11-01",{"date":111,"type":20},"2026-11-01",{"name":113,"class":46},"Zhejiang University"]