[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"icans\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:icans":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100621823","neurological-and-cognitive-dysfunction-following-car-t-treatment-icans-and-beyond-100621823",false,"NCT07375628","Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond","Inclusion Criteria:\n\n* Age \\> 20\n\n  * Planned to undergo CAR-T treatment\n  * No known prior CNS diseases or head trauma\n  * Prior CNS involvement of lymphoma or acute lymphoblastic leukemia is allowed, provided it is well-controlled and treated at inclusion\n  * Capable of receiving tailored information about the research project and signing informed consent\n\nExclusion Criteria:\n\n* • Age under 20 years\n\n  * The patient has previously indicated they wish to refrain from research participation\n  * Another concurrent neuroinflammatory or neurodegenerative disease, or malignant disease (other than the underlying condition) in the central nervous system","ALL","20 Years",{"count":18,"type":19},10,"ESTIMATED","OBSERVATIONAL","This is a phase 4 non-interventional single center trial. We aim to prospectively include patients scheduled to undergo CAR-T therapy at ME CAST, Karolinska University Hospital Huddinge, to study ICANS. Because ICANS develops rapidly, inclusion during this potentially life-threatening phase would not be feasible; patients must therefore be enrolled before they start treatment. We aim to include patients who are clinically at high risk of developing ICANS. The risk of ICANS is assessed based on diagnosis, tumor burden, CAR-T product, and inflammatory status prior to treatment initiation. We plan to compare patients who develop ICANS grade 2-4 with patients who develop no ICANS or at most grade 1. Patients will undergo Positron Emission Tomography (PET) with two different tracers: (1) PBR28 for TSPO, which provides a measure of brain inflammation-this ligand binds to microglial cells-and (2) 11C-UCB-J for SV2A, which provides a measure of synaptic density in the brain. The results will be compared with magnetic resonance imaging. We will collect blood, bone marrow and cerebrospinal fluid (CSF) samples from this patient cohort. Samples will be taken from all patients before, during, and after CAR-T treatment. Participation in the study also includes computer-based cognitive testing, neuropsychological evaluation and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.",[23,24,25],"CAR T Cell Therapy","ICANS","Cognitive and Executive Dysfunction",[27,28,29,30,31],"Icans","CAR T cell therapy","Fatigue","Cognitive dysfunction","PET scan","NOT_YET_RECRUITING","2026-01-22",{"date":35,"type":36},"2026-01-29","ACTUAL",{"date":38,"type":19},"2026-02",{"date":40,"type":19},"2029-05",{"name":42,"class":43},"Karolinska University Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100605972","phase-1-adjunctive-methylene-blue-for-immunotherapy-related-crs-and-icans-phase-i-study-100605972","NCT07169487","Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study","Exploration of Efficacy and Safety of Adjunctive Methylene Blue in the Treatment of Immunotherapy-related CRS and ICANS: A Prospective, Single-arm, Phase I Clinical Study","Inclusion Criteria:\n\n1. Diagnosed with hematologic malignancies based on cytomorphology and immunophenotyping; age ≥18 years.\n2. Received immunotherapy (e.g., CAR-T cells, bispecific antibodies) and developed CRS or ICANS of ASTCT Grade ≥1.\n3. Estimated life expectancy ≥3 months.\n4. Male and female participants of childbearing potential agree to use effective contraception.\n5. Left ventricular ejection fraction (LVEF) \\>45% by echocardiography.\n6. Ability to understand and sign informed consent and willingness to comply with study requirements.\n\nExclusion Criteria:\n\n1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n2. Known allergy to methylene blue.\n3. Pregnant or breastfeeding women.\n4. Known HIV seropositivity. HIV testing may be required according to local laws or regulations.\n5. History of clinically significant ventricular arrhythmia, unexplained syncope (not vasovagal), sinoatrial block, or higher-degree atrioventricular (AV) block with chronic bradycardia (unless a permanent pacemaker is implanted).\n6. Psychiatric disorders that may interfere with completion of treatment or informed consent.\n7. Any other condition deemed unsuitable for participation by the investigator.","18 Years",{"count":53,"type":19},18,"INTERVENTIONAL",[56],"PHASE1","This Phase I, prospective, single-arm clinical study aims to evaluate the efficacy and safety of adjunctive methylene blue (MB) in patients experiencing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following CAR-T cell therapy or bispecific antibody treatment. Preclinical studies demonstrated that MB alleviates CRS\u002FICANS-related symptoms, preserves the antitumor function of T cells, and modulates neuroinflammation without compromising immune efficacy. The study will employ a 3+3 dose-escalation design with three MB dosing cohorts, with treatment administered intravenously for 3-5 consecutive days. Vital signs, laboratory markers, and neurological status will be closely monitored, and concomitant standard supportive therapies will be permitted.",[59,24],"Cytokine Release Syndrome",[61,59,62,63,64],"Methylene Blue","Immune Effector Cell-Associated Neurotoxicity Syndrome","CAR-T Cell Therapy","Immunotherapy-Related Toxicity","RECRUITING","2025-09-05",{"date":68,"type":36},"2025-09-11",{"date":70,"type":36},"2025-06-28",{"date":72,"type":19},"2030-06-28",{"name":74,"class":43},"Institute of Hematology & Blood Diseases Hospital, China",1]