[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485537":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":255,"collaborators":26,"id":257,"slug":26,"hasResults":258,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":26,"eligibilityCriteria":262,"healthyVolunteers":258,"sex":263,"minAge":264,"maxAge":26,"enrollmentInfo":265,"targetDuration":26,"studyType":268,"phases":269,"briefSummary":271,"conditions":272,"keywords":26,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},{"fullName":5,"class":6},"Carna Biosciences, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Dose escalation (3+3 design) and determination of MTD and DLTs\n\nCLL\u002FSLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days).",[13],"Drug: Docirbrutinib",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion","Cohort 1: CLL\u002FSLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL\u002FSLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication\n\nPatients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Docirbrutinib","oral tablet, twice daily",[9,15],[25],"AS-1763",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Akinori Arimura, PhD","CONTACT","650-636-4603","clinical_us@dd.carnabio.com",[34,54,71,87,104,121,138,155,172,189,206,227,238],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"UC Irvine Health","RECRUITING","Orange","California","92868","United States",{"type":42,"coordinates":43},"Point",[44,45],-117.85311,33.78779,{"lat":45,"lon":44},[48,52],{"name":49,"role":30,"phone":50,"phoneExt":26,"email":51},"Catherine Coombs, MD","714-456-8000","ucstudy@hs.uci.edu",{"name":49,"role":53,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":36,"city":56,"state":57,"zip":58,"country":40,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Mount Sinai Comprehensive Cancer Center","Miami Beach","Florida","33140",{"type":42,"coordinates":60},[61,62],-80.13005,25.79065,{"lat":62,"lon":61},[65,69],{"name":66,"role":30,"phone":67,"phoneExt":26,"email":68},"Yvonne Enriquez","305-674-2625","yvonne.enriquez@msmc.com",{"name":70,"role":53,"phone":26,"phoneExt":26,"email":26},"Jacqueline Barrientos, MD",{"facility":72,"status":36,"city":73,"state":57,"zip":74,"country":40,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Moffitt Cancer Center","Tampa","33612",{"type":42,"coordinates":76},[77,78],-82.45843,27.94752,{"lat":78,"lon":77},[81,85],{"name":82,"role":30,"phone":83,"phoneExt":26,"email":84},"Richard Corona","(813) 745-3465","richard.corona@moffitt.org",{"name":86,"role":53,"phone":26,"phoneExt":26,"email":26},"Javier Pinilla-Ibarz, MD PhD",{"facility":88,"status":36,"city":89,"state":90,"zip":91,"country":40,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Northwestern Memorial Hospital","Chicago","Illinois","60661",{"type":42,"coordinates":93},[94,95],-87.65005,41.85003,{"lat":95,"lon":94},[98,102],{"name":99,"role":30,"phone":100,"phoneExt":26,"email":101},"Study Cordinator","(312) 695 1301","cancer@northwestern.edu",{"name":103,"role":53,"phone":26,"phoneExt":26,"email":26},"Shuo Ma, MD PhD",{"facility":105,"status":36,"city":106,"state":107,"zip":108,"country":40,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"American Oncology Partners","Fort Wayne","Indiana","46804",{"type":42,"coordinates":110},[111,112],-85.12886,41.1306,{"lat":112,"lon":111},[115,119],{"name":116,"role":30,"phone":117,"phoneExt":26,"email":118},"Phil Hutson","260-312-2219","phil.hutson@aoncology.com",{"name":120,"role":53,"phone":26,"phoneExt":26,"email":26},"Sunil Babu, MD",{"facility":122,"status":36,"city":123,"state":124,"zip":125,"country":40,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":42,"coordinates":127},[128,129],-76.61219,39.29038,{"lat":129,"lon":128},[132,136],{"name":133,"role":30,"phone":134,"phoneExt":26,"email":135},"Nikki M Glynn-Cunningham, MS","410-328-7996","nglynn@umm.edu",{"name":137,"role":53,"phone":26,"phoneExt":26,"email":26},"Seung Tae Lee, MD PhD",{"facility":139,"status":36,"city":140,"state":141,"zip":142,"country":40,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Massachusetts Memorial Medical Center","Worcester","Massachusetts","01655",{"type":42,"coordinates":144},[145,146],-71.80229,42.26259,{"lat":146,"lon":145},[149,153],{"name":150,"role":30,"phone":151,"phoneExt":26,"email":152},"UMass Cancer Research Office","508-856-3216","cancer.research@umassmed.edu",{"name":154,"role":53,"phone":26,"phoneExt":26,"email":26},"Andrew J Gillis-Smith, MD",{"facility":156,"status":36,"city":157,"state":158,"zip":159,"country":40,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Optum Medical Care PC","Westbury","New York","11590",{"type":42,"coordinates":161},[162,163],-73.58763,40.75566,{"lat":163,"lon":162},[166,171],{"name":167,"role":30,"phone":168,"phoneExt":169,"email":170},"Jonathan Goldberg, MD","914-241-1050","3512","jgoldberg@caremount.com",{"name":167,"role":53,"phone":26,"phoneExt":26,"email":26},{"facility":173,"status":36,"city":174,"state":175,"zip":176,"country":40,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Duke University","Durham","North Carolina","27705",{"type":42,"coordinates":178},[179,180],-78.89862,35.99403,{"lat":180,"lon":179},[183,187],{"name":184,"role":30,"phone":185,"phoneExt":26,"email":186},"Terri Lucas","919-681-6580","terri.lucas@duke.edu",{"name":188,"role":53,"phone":26,"phoneExt":26,"email":26},"Danielle Brander, MD",{"facility":190,"status":36,"city":191,"state":192,"zip":193,"country":40,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Taylor Cancer Research Center","Maumee","Ohio","43537",{"type":42,"coordinates":195},[196,197],-83.65382,41.56283,{"lat":197,"lon":196},[200,204],{"name":201,"role":30,"phone":202,"phoneExt":26,"email":203},"Nadine Nemunaitis","567-402-4501","nnemunaitis@tcrcpt.org",{"name":205,"role":53,"phone":26,"phoneExt":26,"email":26},"John Nemunaitis, MD",{"facility":207,"status":36,"city":208,"state":209,"zip":210,"country":40,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Oncology Consultants","Houston","Texas","77030",{"type":42,"coordinates":212},[213,214],-95.36327,29.76328,{"lat":214,"lon":213},[217,221,225],{"name":218,"role":30,"phone":219,"phoneExt":26,"email":220},"Laura Guerra, RN, CCRC","713-516-4968","lguerra@oncologyconsultants.com",{"name":222,"role":30,"phone":223,"phoneExt":26,"email":224},"Marisol Dominguez","832-333-1480","mdominguez@oncologyconsultants.com",{"name":226,"role":53,"phone":26,"phoneExt":26,"email":26},"Julio A Peguero, MD",{"facility":228,"status":36,"city":208,"state":209,"zip":210,"country":40,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"University of Texas MD Anderson Cancer Center",{"type":42,"coordinates":230},[213,214],{"lat":214,"lon":213},[233,237],{"name":234,"role":30,"phone":235,"phoneExt":26,"email":236},"Nitin Jain, MD","713-745-6080","njain@mdanderson.org",{"name":234,"role":53,"phone":26,"phoneExt":26,"email":26},{"facility":239,"status":36,"city":240,"state":241,"zip":242,"country":40,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"The Medical College of Wisconsin","Milwaukee","Wisconsin","53266",{"type":42,"coordinates":244},[245,246],-87.90647,43.0389,{"lat":246,"lon":245},[249,253],{"name":250,"role":30,"phone":251,"phoneExt":26,"email":252},"Medical College of Wisconsin Cancer Center Clinical Trials Office","414-805-8900","cccto@mcw.edu",{"name":254,"role":53,"phone":26,"phoneExt":26,"email":26},"Nirav Shah, MD",{"type":256,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100485537",false,"NCT05602363","AS-1763 in Patients With Previously Treated CLL\u002FSLL or Non-Hodgkin Lymphoma","A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma or Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Provided written informed consent\n* Histologically confirmed B-cell malignancy, including CLL\u002FSLL, WM, MCL, MZL, or FL\n* Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion\n* Failed or are intolerant to ≥2 prior lines of systemic therapy\n* ECOG Performance Status 0 to 2\n* Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹\u002FL, platelet count ≥50 × 10⁹\u002FL, hemoglobin ≥8 g\u002FdL) not requiring transfusion support or growth factors\n* Adequate hepatic function\n* Adequate renal function\n* Ability to swallow tablets and comply with study requirements for the duration of study participation\n* Male and female patients of reproductive potential: Willing to observe conventional and effective birth control methods\n* Male patients: agree not to donate sperm during and for 6 months after the study\n* Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication\n\nExclusion Criteria:\n\n* Transformed disease (eg, Richter's transformation) prior to or during Screening\n* Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib\n* Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study\n* Requiring therapeutic anticoagulation with warfarin\n* Current treatment with certain strong CYP3A4 inhibitors or inducers\n* Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib\n* Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors\n* Refractory to transfusion support\n* Major surgery within 4 weeks before planned start of docirbrutinib\n* Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment\n* Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia\n* History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days\n* Active second malignancy unless in remission with life expectancy \\>2 years\n* Known central nervous system (CNS) involvement by systemic lymphoma\n* Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts\n* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) \\>470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF \\>470 msec on all 3 ECGs, during Screening\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Positive for HIV. For patients with unknown HIV status, HIV testing will be performed at Screening\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of docirbrutinib\n* Pregnant or lactating.\n* Known hypersensitivity to any component or excipient of docirbrutinib\n* Prior treatment with docirbrutinib\n* Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)\n* Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi","ALL","18 Years",{"count":266,"type":267},120,"ESTIMATED","INTERVENTIONAL",[270],"PHASE1","This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL\u002FSLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.",[273,274,275,276,277,278,279,280],"B-cell Malignancy","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Waldenstrom Macroglobulinemia","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","2025-12-09",{"date":283,"type":284},"2025-12-10","ACTUAL",{"date":286,"type":284},"2023-08-01",{"date":288,"type":267},"2027-09",{"name":5,"class":6},13]