[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485537":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":256,"collaborators":26,"id":258,"slug":259,"hasResults":260,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":26,"eligibilityCriteria":264,"healthyVolunteers":260,"sex":265,"minAge":266,"maxAge":26,"enrollmentInfo":267,"targetDuration":26,"studyType":270,"phases":271,"briefSummary":273,"conditions":274,"keywords":26,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},{"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",[34,55,72,88,105,122,139,156,173,190,207,228,239],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"UC Irvine Health","RECRUITING","Orange","California","92868","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-117.85311,33.78779,{"lat":46,"lon":45},[49,53],{"name":50,"role":30,"phone":51,"phoneExt":26,"email":52},"Catherine Coombs, MD","714-456-8000","ucstudy@hs.uci.edu",{"name":50,"role":54,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":56,"status":36,"city":57,"state":58,"zip":59,"country":40,"countryCode":41,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Mount Sinai Comprehensive Cancer Center","Miami Beach","Florida","33140",{"type":43,"coordinates":61},[62,63],-80.13005,25.79065,{"lat":63,"lon":62},[66,70],{"name":67,"role":30,"phone":68,"phoneExt":26,"email":69},"Yvonne Enriquez","305-674-2625","yvonne.enriquez@msmc.com",{"name":71,"role":54,"phone":26,"phoneExt":26,"email":26},"Jacqueline Barrientos, MD",{"facility":73,"status":36,"city":74,"state":58,"zip":75,"country":40,"countryCode":41,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Moffitt Cancer Center","Tampa","33612",{"type":43,"coordinates":77},[78,79],-82.45843,27.94752,{"lat":79,"lon":78},[82,86],{"name":83,"role":30,"phone":84,"phoneExt":26,"email":85},"Richard Corona","(813) 745-3465","richard.corona@moffitt.org",{"name":87,"role":54,"phone":26,"phoneExt":26,"email":26},"Javier Pinilla-Ibarz, MD PhD",{"facility":89,"status":36,"city":90,"state":91,"zip":92,"country":40,"countryCode":41,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Northwestern Memorial Hospital","Chicago","Illinois","60661",{"type":43,"coordinates":94},[95,96],-87.65005,41.85003,{"lat":96,"lon":95},[99,103],{"name":100,"role":30,"phone":101,"phoneExt":26,"email":102},"Study Cordinator","(312) 695 1301","cancer@northwestern.edu",{"name":104,"role":54,"phone":26,"phoneExt":26,"email":26},"Shuo Ma, MD PhD",{"facility":106,"status":36,"city":107,"state":108,"zip":109,"country":40,"countryCode":41,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"American Oncology Partners","Fort Wayne","Indiana","46804",{"type":43,"coordinates":111},[112,113],-85.12886,41.1306,{"lat":113,"lon":112},[116,120],{"name":117,"role":30,"phone":118,"phoneExt":26,"email":119},"Phil Hutson","260-312-2219","phil.hutson@aoncology.com",{"name":121,"role":54,"phone":26,"phoneExt":26,"email":26},"Sunil Babu, MD",{"facility":123,"status":36,"city":124,"state":125,"zip":126,"country":40,"countryCode":41,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":43,"coordinates":128},[129,130],-76.61219,39.29038,{"lat":130,"lon":129},[133,137],{"name":134,"role":30,"phone":135,"phoneExt":26,"email":136},"Nikki M Glynn-Cunningham, MS","410-328-7996","nglynn@umm.edu",{"name":138,"role":54,"phone":26,"phoneExt":26,"email":26},"Seung Tae Lee, MD PhD",{"facility":140,"status":36,"city":141,"state":142,"zip":143,"country":40,"countryCode":41,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"University of Massachusetts Memorial Medical Center","Worcester","Massachusetts","01655",{"type":43,"coordinates":145},[146,147],-71.80229,42.26259,{"lat":147,"lon":146},[150,154],{"name":151,"role":30,"phone":152,"phoneExt":26,"email":153},"UMass Cancer Research Office","508-856-3216","cancer.research@umassmed.edu",{"name":155,"role":54,"phone":26,"phoneExt":26,"email":26},"Andrew J Gillis-Smith, MD",{"facility":157,"status":36,"city":158,"state":159,"zip":160,"country":40,"countryCode":41,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Optum Medical Care PC","Westbury","New York","11590",{"type":43,"coordinates":162},[163,164],-73.58763,40.75566,{"lat":164,"lon":163},[167,172],{"name":168,"role":30,"phone":169,"phoneExt":170,"email":171},"Jonathan Goldberg, MD","914-241-1050","3512","jgoldberg@caremount.com",{"name":168,"role":54,"phone":26,"phoneExt":26,"email":26},{"facility":174,"status":36,"city":175,"state":176,"zip":177,"country":40,"countryCode":41,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Duke University","Durham","North Carolina","27705",{"type":43,"coordinates":179},[180,181],-78.89862,35.99403,{"lat":181,"lon":180},[184,188],{"name":185,"role":30,"phone":186,"phoneExt":26,"email":187},"Terri Lucas","919-681-6580","terri.lucas@duke.edu",{"name":189,"role":54,"phone":26,"phoneExt":26,"email":26},"Danielle Brander, MD",{"facility":191,"status":36,"city":192,"state":193,"zip":194,"country":40,"countryCode":41,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Taylor Cancer Research Center","Maumee","Ohio","43537",{"type":43,"coordinates":196},[197,198],-83.65382,41.56283,{"lat":198,"lon":197},[201,205],{"name":202,"role":30,"phone":203,"phoneExt":26,"email":204},"Nadine Nemunaitis","567-402-4501","nnemunaitis@tcrcpt.org",{"name":206,"role":54,"phone":26,"phoneExt":26,"email":26},"John Nemunaitis, MD",{"facility":208,"status":36,"city":209,"state":210,"zip":211,"country":40,"countryCode":41,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Oncology Consultants","Houston","Texas","77030",{"type":43,"coordinates":213},[214,215],-95.36327,29.76328,{"lat":215,"lon":214},[218,222,226],{"name":219,"role":30,"phone":220,"phoneExt":26,"email":221},"Laura Guerra, RN, CCRC","713-516-4968","lguerra@oncologyconsultants.com",{"name":223,"role":30,"phone":224,"phoneExt":26,"email":225},"Marisol Dominguez","832-333-1480","mdominguez@oncologyconsultants.com",{"name":227,"role":54,"phone":26,"phoneExt":26,"email":26},"Julio A Peguero, MD",{"facility":229,"status":36,"city":209,"state":210,"zip":211,"country":40,"countryCode":41,"cosmosGeoPoint":230,"geoPoint":232,"contacts":233},"University of Texas MD Anderson Cancer Center",{"type":43,"coordinates":231},[214,215],{"lat":215,"lon":214},[234,238],{"name":235,"role":30,"phone":236,"phoneExt":26,"email":237},"Nitin Jain, MD","713-745-6080","njain@mdanderson.org",{"name":235,"role":54,"phone":26,"phoneExt":26,"email":26},{"facility":240,"status":36,"city":241,"state":242,"zip":243,"country":40,"countryCode":41,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"The Medical College of Wisconsin","Milwaukee","Wisconsin","53266",{"type":43,"coordinates":245},[246,247],-87.90647,43.0389,{"lat":247,"lon":246},[250,254],{"name":251,"role":30,"phone":252,"phoneExt":26,"email":253},"Medical College of Wisconsin Cancer Center Clinical Trials Office","414-805-8900","cccto@mcw.edu",{"name":255,"role":54,"phone":26,"phoneExt":26,"email":26},"Nirav Shah, MD",{"type":257,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100485537","phase-1-as-1763-in-patients-with-previously-treated-cllsll-or-non-hodgkin-lymphoma-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":268,"type":269},120,"ESTIMATED","INTERVENTIONAL",[272],"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.",[275,276,277,278,279,280,281,282],"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":285,"type":286},"2025-12-10","ACTUAL",{"date":288,"type":286},"2023-08-01",{"date":290,"type":269},"2027-09",{"name":5,"class":6},13]