[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carna Biosciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33],"B-cell Malignancy","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Waldenstrom Macroglobulinemia","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","RECRUITING","2025-12-09",{"date":37,"type":38},"2025-12-10","ACTUAL",{"date":40,"type":38},"2023-08-01",{"date":42,"type":20},"2027-09",{"name":44,"class":45},"Carna Biosciences, Inc.","INDUSTRY",13,""]