[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508815":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":158,"collaborators":30,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":30,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":30,"enrollmentInfo":169,"targetDuration":30,"studyType":172,"phases":173,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"CytoAgents, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CTO1681 30 μg Total Daily Dose","EXPERIMENTAL","Participants receive 10 μg CTO1681 orally 3 times daily (total daily dose of 30 μg) for 15 days.",[13],"Drug: CTO1681 10 μg",{"label":15,"type":10,"description":16,"interventionNames":17},"CTO1681 60 μg Total Daily Dose","Participants receive 20 μg CTO1681 orally 3 times daily (total daily dose of 60 μg) for 15 days.",[18],"Drug: CTO1681 20 μg",{"label":20,"type":10,"description":21,"interventionNames":22},"CTO1681 90 μg Total Daily Dose","Participants receive 30 μg CTO1681 orally 3 times daily (total daily dose of 90 μg) for 15 days.",[23],"Drug: CTO1681 30 μg",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","CTO1681 10 μg","Administered 3 times daily for 15 days (initial cohort).",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"CTO1681 20 μg","Administered 3 times daily for 15 days (successive cohort).",[15],{"type":26,"name":36,"description":33,"armGroupLabels":37,"otherNames":30},"CTO1681 30 μg",[20],[39],{"name":40,"affiliation":5,"role":41},"Mike Howell, PhD","STUDY_CHAIR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Gail Brown, MD","CONTACT","650-868-2182","gail@tekteam.net",{"name":49,"role":45,"phone":30,"phoneExt":30,"email":50},"Heather Nottingham, PhD","heather@tekteam.net",[52,74,91,107,124,141],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of California, Irvine - Chao Family Comprehensive Cancer Center","RECRUITING","Orange","California","92868","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.85311,33.78779,{"lat":64,"lon":63},[67,71],{"name":68,"role":45,"phone":69,"phoneExt":30,"email":70},"Blake Johnson","714-456-3476","blakej@hs.uci.edu",{"name":72,"role":73,"phone":30,"phoneExt":30,"email":30},"Stefan Ciurea, MD","PRINCIPAL_INVESTIGATOR",{"facility":75,"status":54,"city":76,"state":77,"zip":78,"country":58,"countryCode":59,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Georgia Cancer Center at Augusta University","Augusta","Georgia","30912",{"type":61,"coordinates":80},[81,82],-81.97484,33.47097,{"lat":82,"lon":81},[85,89],{"name":86,"role":45,"phone":87,"phoneExt":30,"email":88},"Rebecca Paynter, MSN, RN","706-446-5177","rpaynter@augusta.edu",{"name":90,"role":73,"phone":30,"phoneExt":30,"email":30},"Yenny Moreno, MD",{"facility":92,"status":54,"city":93,"state":94,"zip":95,"country":58,"countryCode":59,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":61,"coordinates":97},[98,99],-71.05977,42.35843,{"lat":99,"lon":98},[102,106],{"name":103,"role":45,"phone":104,"phoneExt":30,"email":105},"Jon Arnason, MD","617-667-9920","jarnason@bidmc.harvard.edu",{"name":103,"role":73,"phone":30,"phoneExt":30,"email":30},{"facility":108,"status":54,"city":109,"state":110,"zip":111,"country":58,"countryCode":59,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Duke Cancer Institute","Durham","North Carolina","27705",{"type":61,"coordinates":113},[114,115],-78.89862,35.99403,{"lat":115,"lon":114},[118,122],{"name":119,"role":45,"phone":120,"phoneExt":30,"email":121},"Jennifer Tichon, BSN, RN","919-660-7262","jennifer.tichon@duke.edu",{"name":123,"role":73,"phone":30,"phoneExt":30,"email":30},"Chenyu Lin, MD",{"facility":125,"status":54,"city":126,"state":127,"zip":128,"country":58,"countryCode":59,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15232",{"type":61,"coordinates":130},[131,132],-79.99589,40.44062,{"lat":132,"lon":131},[135,139],{"name":136,"role":45,"phone":137,"phoneExt":30,"email":138},"Linda Elias, BSN, RN","412-623-6037","eliaslj@upmc.edu",{"name":140,"role":73,"phone":30,"phoneExt":30,"email":30},"Alison Sehgal, MD",{"facility":142,"status":54,"city":143,"state":144,"zip":145,"country":58,"countryCode":59,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":61,"coordinates":147},[148,149],-122.33207,47.60621,{"lat":149,"lon":148},[152,156],{"name":153,"role":45,"phone":154,"phoneExt":30,"email":155},"Immunotherapy Intake","206-606-4668","immunotherapy@fredhutch.org",{"name":157,"role":73,"phone":30,"phoneExt":30,"email":30},"Jordan Gauthier, MD, MSc",{"type":159,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100508815","phase-1-study-of-cto1681-for-the-prevention-and-treatment-of-crs-in-dlbcl-patients-receiving-car-t-cell-therapy-100508815",false,"NCT05905328","Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy","Phase 1B\u002F2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients With Diffuse Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Undergone leukapheresis and is scheduled to receive protocol-specified commercially available CD19-directed CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) for DLBCL without corticosteroid prophylaxis for CRS and\u002For ICANS. Patients eligible for study must have relapsed or refractory DLBCL after at least one prior line of systemic therapy.\n3. Met all inclusion criteria for CAR T-cell therapy per institutional guidelines.\n4. Adequate organ function defined as:\n\n   1. Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL\u002Fmin.\n   2. Serum alanine aminotransferase\u002Faspartate aminotransferase ≤ 2.5 × ULN.\n   3. Total bilirubin ≤ 1.5 × ULN.\n   4. Left ventricular ejection fraction ≥ 40% on echocardiogram or multigated acquisition and no clinically significant pericardial effusion.\n   5. Platelets ≥ 50,000\u002Fmm3.\n   6. Absolute neutrophil count \\> 1000\u002FμL.\n   7. Absolute lymphocyte count \\> 100\u002FμL.\n5. Documented measurable lymphoma disease adequate to judge by Lugano Criteria.\n6. Eastern Cooperative Oncology Group performance status 0 to 1.\n7. Female participants of childbearing potential and all male participants must agree to use Investigator-approved methods of birth control while on study drug and for 30 days thereafter.\n8. Patients who are willing to provide written informed consent before the predose procedures, or patients who have a legal representative capable of providing informed consent on their behalf.\n\nExclusion Criteria:\n\n1. Any cytotoxic chemotherapy within 14 days prior to leukapheresis.\n2. Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.\n3. Grade 2 or greater electrolyte imbalance, per CTCAE v5.0:\n\n   1. Potassium \\\u003C 3.0 or \\> 5.5 mmol\u002FL\n   2. Sodium \\\u003C 130 or \\> 150 mmol\u002FL\n   3. Calcium \\\u003C 8.0 or \\> 11.5 mg\u002FdL\n   4. Magnesium \\\u003C 0.5 or \\> 1.23 mmol\u002FL\n4. Clinically significant ECG abnormality at Screening or Baseline (Day -1), including but not limited to, a confirmed QTcF value \\> 470 msec. Patients to be excluded included those with QTcF readings that are borderline or difficult to interpret because of a condition such as bundle branch block, or in those where the end of the T wave is difficult to measure. This also includes any Grade 2 or greater conduction block disorder, atrial, or ventricular arrythmia.\n5. History of clinically significant arrhythmia and\u002For requiring anticoagulation\u002Fantiplatelet treatment at therapeutic dose.\n6. Any clinically significant (ie, active) cardiovascular disease, including cerebral vascular accident\u002Fstroke (\\\u003C 6 months before enrollment), myocardial infarction (\\\u003C 6 months before enrollment) or unstable angina, and congestive heart failure ≥ New York Heart Association Classification Class III.\n7. Uncontrolled thromboembolic events or recent severe hemorrhage within the last 6 months.\n8. Known history of any bleeding disorder.\n9. Requirement for ongoing therapeutic doses of anticoagulant therapy, antiplatelet or fibrinolytic agents (low molecular weight heparin prophylaxis is allowed).\n10. Baseline systolic blood pressure \\\u003C100 mmHg.\n11. History of autoimmune disease\u002F graft versus host disease requiring immunosuppressive therapy within the last 2 years. However, physiologic steroids (prednisone equivalent) may be given at a dose of 5 mg or less.\n12. Patients who, in the opinion of the Investigator, would be unlikely to comply with study procedures or are otherwise unsuitable for enrollment.","ALL","18 Years",{"count":170,"type":171},54,"ESTIMATED","INTERVENTIONAL",[174,175],"PHASE1","PHASE2","This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy.\n\nThe first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.",[178],"Cytokine Release Syndrome",[180,181,182,183,184],"Cytokine release syndrome","Cytokine storm","Hypercytokinemia","Immunotoxicity","CAR T-cell therapy","2026-04-14",{"date":187,"type":188},"2026-04-17","ACTUAL",{"date":190,"type":188},"2023-12-28",{"date":192,"type":171},"2027-06",{"name":5,"class":6},6]