[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cart-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cart-therapy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,84,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100616737","pragmatic-geriatric-assessment-before-car-t-or-bispecific-antibody-therapy-to-predict-side-effects-and-outcomes-in-older-patients-ga-act-trial-100616737",false,"NCT07309497","Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)","Pragmatic Geriatric Assessment (pGA) Before Bispecific Antibody and CAR-T-Cell Therapy (GA-ACT Trial) for the Prediction of Toxicity and Outcomes in Older Patients Scheduled for Chimeric Antigen Receptor T-Cell Therapy (CAR-T-Cell-Therapy) or Bispecific Antibody (bsAB) Treatment","GA-ACT","Inclusion Criteria:\n\n* male or female patients age ≥ 65 years,\n* scheduled for CAR-T-cell or bsAB treatments\n* signed informed consent\n* sufficient knowledge of the German or French language\n\nExclusion Criteria:\n\n* inability to understand or sign informed consent\n* refuse to consent","ALL","65 Years",{"count":20,"type":21},208,"ESTIMATED","OBSERVATIONAL","CAR-T cell or bispecific antibody therapies are a new treatment option for adult patients with aggressive forms of lymphoma or so-called plasma cell diseases ('multiple myeloma', 'plasma cell myeloma') that could not be cured with other, less intensive approaches. However, these are intensive therapies that can be associated with severe and potentially life-threatening side effects. Although there is no age limit for these therapies, we know little about the short- and long-term side effects of these treatments in people of advanced age.\n\nAlthough a small number of patients in the pivotal studies were even over 80 years old, their number was too small to be able to assess the tolerability and success specifically in people over 65. At present, the treating physicians decide whether and, if so, which patients are considered 'fit' enough for this therapy. An objective assessment of the kind we want to investigate in our study does not currently exist on a regular basis. In this study, we therefore want to use simple clinical methods to investigate the effects of these forms of therapy in different areas of everyday function that are important for people in older age (mobility, memory, self-care skills, nutrition). We want to find out whether these investigations help to predict the risk of severe and\u002For long-term side effects. Based on the results, a pragmatic geriatric assessment could be introduced as standard before these therapies. Older patients could thus expect an improvement in their quality of life thanks to more predictable risks and side effects. Standardized screening could lead to lower healthcare costs for treatment and aftercare for both forms of therapy.",[25,26,27,28],"Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","CART Therapy","Bispecific Antibody","Geriatric Hematology",[30,31,32,33,34,35,36,37],"geriatric assessment","lymphoma","multiple myeloma","bispecific antibodies","chimeric antigen receptor","outcome assessment","toxicity","health related quality of life","RECRUITING","2025-12-15",{"date":41,"type":42},"2025-12-30","ACTUAL",{"date":44,"type":42},"2025-12-12",{"date":46,"type":21},"2028-02-01",{"name":48,"class":49},"University of Zurich","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100596903","early-versus-late-stopping-of-antibiotics-in-adults-with-high-risk-hematological-malignanciesreceiving-cellular-therapies-and-fever-100596903","NCT07051525","Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies\u002FReceiving Cellular Therapies and Fever","Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies\u002FReceiving Cellular Therapies and Fever (ELSA- Adult)","ELSA-Adult","Inclusion Criteria:\n\nAdult patients ( ≥18 years) who are receiving either:\n\n* Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR\n* Induction remission chemotherapy for acute leukaemia,\n\nAND develop fever ( ≥38degC) between time of initiation of chemotherapy\u002Fconditioning administration and ANC recovery to ≥500 cells\u002Fmm3 post the ANC nadir,\n\nAND fever subsequently has settled (\\\u003C38degC) for ≥48 and \\\u003C96h hours.\n\n\\[participants will be stratified into pre-neutropenic (ANC ≥500 cells\u002Fmm3) and neutropenic (ANC\\\u003C500 cells\u002Fmm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\\]\n\nExclusion Criteria:\n\n* \\- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)\n* Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation\n* Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment\n* Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis\n* Clinically unstable and\u002For admission to ICU at time of potential randomization\n* Within 28 days of last randomization\n* Prior randomization during current chemotherapy\u002Fconditioning cycle\n* Pregnant or breastfeeding\n* Currently being treated for CRS Grade 3 or 4, and\u002For ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)","18 Years",{"count":61,"type":21},214,"INTERVENTIONAL",[64],"NA","Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.",[67,26,68,69],"Leukemia","Transplantation, Stem Cell","Infections, Bacterial",[71,72,73,74,75],"EPIC","ELSA","Febrile neutropaenia","Febrile neutropenia","antibitoics","2025-12-07",{"date":39,"type":42},{"date":79,"type":42},"2025-12-03",{"date":81,"type":21},"2028-02-05",{"name":83,"class":49},"Peter MacCallum Cancer Centre, Australia",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":62,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100569497","phase-2-immunobridgingmaintenance-therapy-versus-non-bridging-therapy-in-car-t-therapy-for-low-risk-rr-b-nhl-100569497","NCT06695013","Immunobridging\u002FMaintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R\u002FR B-NHL","Immunobridging\u002FMaintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk Relapsed\u002FRefractory B Cell Non-Hodgkin Lymphoma(R\u002FR B-NHL): A Multicenter, Prospective, Randomized, Open-label, Controlled Clinical Study","CART R\u002FR NHL","Inclusion Criteria:\n\n1. Age 18 or older, regardless of gender.\n2. Histologically confirmed B-cell non-Hodgkin lymphoma, according to Lugano diagnostic criteria.\n3. At least first-line treatment for relapsed or refractory patients, including chemotherapy regimens containing anthracyclines and anti-CD20 monoclonal antibody therapy; patients must meet definitions of refractory and recurrent.\n4. No prior CD19 CAR T cell therapy.\n5. Adequate organ function to assess tolerance to CAR-T therapy.\n6. Sufficient vascular access for leukapheresis.\n7. Ability to provide written informed consent and understand the study requirements and evaluation schedule.\n8. Fertile patients must agree to use highly effective contraception during the study and for 120 days post-treatment.\n\nExclusion criteria：\n\nPatients with any of the following conditions will not be included in the study:\n\n1. History of allogeneic hematopoietic stem cell transplantation.\n2. History of epilepsy, cerebrovascular ischemia\u002Fbleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.\n3. Any other malignancies within the past 2 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1).\n4. Severe cardiovascular disease: NYHA grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; NYHA grade III to IV heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n5. Allergy to any investigational drug or excipient.\n6. Active viral hepatitis requiring treatment, including chronic HBV carriers with HBV DNA ≥ 500 IU\u002FmL and positive HCV RNA.\n7. Active autoimmune disease or known history of allogeneic organ transplantation; long-term heavy use of immunosuppressants or other factors affecting study therapy.\n8. Active infection.\n9. History of uncontrolled systemic disease, such as diabetes or hypertension.\n10. Known HIV infection.\n11. Underlying medical condition or substance abuse that may interfere with drug administration or affect result interpretation, or increase treatment risk.\n12. End-organ damage from autoimmune disease within the past 2 years or systemic use of immunosuppressive drugs.",{"count":93,"type":21},144,[95],"PHASE2","This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory\u002Frelapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.",[98,26],"B-NHL",[100,101],"Zanubrutinib","maintenance","2025-01-22",{"date":104,"type":42},"2025-01-24",{"date":106,"type":42},"2024-11-20",{"date":108,"type":21},"2027-03-20",{"name":110,"class":49},"Ruijin Hospital",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":62,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":111},"100572378","phase-1-rd13-02-cell-injection-in-patients-with-relapsed-or-refractory-cd7-positive-natural-killert-cell-malignancies-100572378","NCT06732492","RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer\u002FT Cell Malignancies","Inclusion Criteria:\n\n1. Age 3-70\n2. Diagnosis of r\u002Fr NK\u002FT lymphoma.\n3. CD7 positive expression\n4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening\n5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL\u002Fmin, Serum alanine aminotransferase(ALT)\u002Faspartate aminotransferase(AST) \\\u003C 3×upper limit of normal, Total bilirubin \\\u003C 1.5×upper limit of normal or ≤1.5mg\u002Fdl\n6. Left ventricular ejection fraction ≥ 50% .\n7. Baseline oxygen saturation ≥ 92% on room air.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n9. The estimated survival time is more than 3 months.\n10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Subjects with concomitant genetic syndromes associated with bone marrow failure states.\n2. Isolated extramedullary lesions\n3. Subjects with some cardiac conditions will be excluded.\n4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).\n5. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.\n6. History of malignancy other than non-melanoma skin cancer or carcinoma.\n7. Primary immune deficiency.\n8. Presence of uncontrolled infections.\n9. Subjects with some anticancer therapy before CAR-T infusion will be excluded.\n10. Active uncontrolled acute infections.\n11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.\n12. Subjects who are receiving systemic steroid therapy prior to screening.","3 Years","70 Years",{"count":121,"type":21},10,[123],"PHASE1","This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer\u002FT cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。",[126,26,127],"NK T-Cell Lymphoma","CD7-positive Relapsed\u002FRefractory Lymphoid Hematologic Malignancies","2024-12-10",{"date":130,"type":42},"2024-12-13",{"date":132,"type":42},"2024-10-31",{"date":134,"type":21},"2027-12-31",{"name":136,"class":49},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology"]