[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjunctive Methylene Blue Dose-Escalation in Immunotherapy-related CRS and ICANS","EXPERIMENTAL","To evaluate the efficacy and safety of adjunctive methylene blue in the treatment of immunotherapy-related cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients receiving CAR-T or bispecific antibody therapy, using a 3+3 dose-escalation Phase I design.",[13],"Drug: Methylene Blue",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Methylene Blue","Intravenous infusion of methylene blue once daily for 3-5 consecutive days at doses of 1 mg\u002Fkg, 2 mg\u002Fkg, or 3 mg\u002Fkg, administered over 20 minutes, following CAR-T or bispecific antibody infusion in patients who develop Grade ≥1 CRS or ICANS.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jianxiang Wang","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+862223909120","wangjx@ihcams.ac",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Institute of Hematology & Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":39,"coordinates":40},"Point",[41,42],117.17667,39.14222,{"lat":42,"lon":41},[45,48],{"name":23,"role":27,"phone":46,"phoneExt":20,"email":47},"022-23909120","wangjx@ihcams.ac.cn",{"name":49,"role":24,"phone":20,"phoneExt":20,"email":20},"Ying Wang",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100605972","phase-1-adjunctive-methylene-blue-for-immunotherapy-related-crs-and-icans-phase-i-study-100605972",false,"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.","ALL","18 Years",{"count":62,"type":63},18,"ESTIMATED","INTERVENTIONAL",[66],"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.",[69,70],"Cytokine Release Syndrome","ICANS",[17,69,72,73,74],"Immune Effector Cell-Associated Neurotoxicity Syndrome","CAR-T Cell Therapy","Immunotherapy-Related Toxicity","2025-09-05",{"date":77,"type":78},"2025-09-11","ACTUAL",{"date":80,"type":78},"2025-06-28",{"date":82,"type":63},"2030-06-28",{"name":5,"class":6},1]