[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491790":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":32,"locations":38,"responsibleParty":59,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"TransThera Sciences (Nanjing), Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation for TT-01488","EXPERIMENTAL","TT-01488 tablets will be administered once daily in a 28-day cycle in increasing strength in order to determine the recommended dose for dose expansion.",[13],"Drug: TT-01488 Tablets",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion for TT-01488","TT-01488 tablets will be administered once daily in 28-day cycles to verify the safety and preliminary efficacy as observed in the dose escalation cohorts.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","TT-01488 Tablets","TT-01488 tablet will be administered orally once daily per protocol defined schedule.",[9,15],null,[26,30],{"name":27,"affiliation":28,"role":29},"Li Jianyong","The First Affiliated Hospital with Nanjing Medical University","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Xu Wei",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Sun Caixia, PhD","CONTACT","025-58216298","clinicaltrial@transtherabio.com",[39],{"facility":28,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],118.77778,32.06167,{"lat":50,"lon":49},[53,56],{"name":54,"role":35,"phone":24,"phoneExt":24,"email":55},"Jianyong Li, M.D.","lijianyonglm@126.com",{"name":57,"role":35,"phone":24,"phoneExt":24,"email":58},"Wei Xu, M.D.","xuwei10000@hotmail.com",{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100491790","phase-1-a-phase-1-study-to-evaluate-the-safety-and-tolerability-of-tt-01488-in-patients-with-b-cell-malignancies-100491790",false,"NCT05683717","A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies","A Phase I, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies","Inclusion Criteria:\n\n* Participants with histologically confirmed B-cell malignancy, failed or intolerant to either ≥ 2 prior standard\u002Fcommon regimens given in combination or sequentially OR have received 1 prior BTK-containing regimen, relapse\u002Frefractory, and with treatment indication:\n\n  * CLL\u002FSLL treated with prior immunochemistry or BTK inhibitor containing regimen;\n  * DLBCL treated with prior CD20 or anthracyclines containing regimen;\n  * Other types of B-cell NHL treated with prior CD20 containing regimen\n* Adequate organ function, defined by the following laboratory parameters:\n\n  * Hematologic:\n* Absolute neutrophil count (ANC) ≥ 0.75×10\\^9\u002FL, and ≥ 0.5×10\\^9\u002FL if bone marrow involved\n* Platelets ≥ 50×10\\^9\u002FL without transfusion within 7 days, and ≥ 30×10\\^9\u002FL if bone marrow involved\n* Hemoglobin ≥ 8.0 g\u002FdL without transfusion within 7 days, and ≥ 7.0 g\u002FdL if bone marrow involved\n\n  * Coagulation:\n* Prothrombin time (PT) ≤ 1.5 × ULN\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n\n  * Renal function:\n* Creatinine clearance ≥ 30 mL\u002Fmin estimated glomerular filtration rate based on Cockcroft-Gault formula\n\n  * Liver function:\n* Total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's disease)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN unless disease-related\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to \\\u003C 2 years (Note: these cases must be discussed with the Medical Monitor and\u002For Investigator)\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days or with any of the following:\n\n  * Active graft versus host disease (GvHD);\n  * Cytopenias from incomplete blood cell count recovery post-transplant;\n  * Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n  * Ongoing immunosuppressive therapy\n* Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation","ALL","18 Years",{"count":71,"type":72},37,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.",[78],"B-Cell Malignancies","2023-11-20",{"date":81,"type":82},"2023-11-21","ACTUAL",{"date":84,"type":82},"2023-03-30",{"date":86,"type":72},"2028-10-30",{"name":5,"class":6},1]