[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658768":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":11,"armGroups":55,"interventions":82,"overallOfficials":11,"centralContacts":98,"locations":104,"responsibleParty":137,"collaborators":11,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":11,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":11,"enrollmentInfo":148,"targetDuration":11,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":11,"overallStatus":157,"whyStopped":11,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"TransThera Sciences (Nanjing), Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part A Dose-limiting toxicity (DLT)",null,"At the end of Cycle 1 (each cycle is 28 days)",{"measure":14,"description":11,"timeFrame":15},"Part B Complete Response Rate (CRR) After 6 Cycles of Induction Therapy","After 6 cycles of induction therapy (each cycle is 28 days)",[17,20,22,24,26,28,30,32,34,36,38,40,42,44,46],{"measure":18,"description":11,"timeFrame":19},"Part A Maximum Plasma Concentration (Cmax) of TT-01488","Up to 60 months",{"measure":21,"description":11,"timeFrame":19},"Part A Time to Reach Maximum Plasma Concentration (Tmax) of TT-01488",{"measure":23,"description":11,"timeFrame":19},"Part A Terminal Half-Life (t1\u002F2) of TT-01488",{"measure":25,"description":11,"timeFrame":19},"Part A Area Under the Plasma Concentration-Time Curve During the Dosing Interval (AUCtau) of TT-01488",{"measure":27,"description":11,"timeFrame":19},"Part A Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC0-t) of TT-01488",{"measure":29,"description":11,"timeFrame":15},"Part B Objective Response Rate (ORR) After 6 cycles of induction therapy",{"measure":31,"description":11,"timeFrame":19},"Part B Best Objective Response Rate (ORR) During Treatment",{"measure":33,"description":11,"timeFrame":19},"Part B Best Complete Response Rate (CRR) During Treatment",{"measure":35,"description":11,"timeFrame":19},"Part B Time to Response (TTR)",{"measure":37,"description":11,"timeFrame":19},"Part B Duration of Response (DOR)",{"measure":39,"description":11,"timeFrame":19},"Part B PFS rates at 12, 24, 36, 48, and 60 months",{"measure":41,"description":11,"timeFrame":19},"Part B OS rates at 12, 24, 36, 48, and 60 months",{"measure":43,"description":11,"timeFrame":19},"Part B Safety and Tolerability",{"measure":45,"description":11,"timeFrame":19},"PartＢChange From Baseline in EQ-5D-5L Utility Index Score",{"measure":47,"description":11,"timeFrame":19},"Part B Change From Baseline in Global Health Status\u002FQuality of Life Using the EORTC QLQ-C30",{"allocation":49,"interventionModel":50,"interventionModelDescription":11,"primaryPurpose":51,"observationalModel":11,"timePerspective":11,"maskingInfo":52},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":53,"maskingDescription":11,"whoMasked":11},"NONE","The study comprises three combination treatment cohorts: Cohort A, TT-01488 plus rituximab; Cohort B, TT-01488 plus rituximab plus an immunomodulatory agent; and Cohort C, TT-01488 plus rituximab plus a BCL2 inhibitor. Each treatment cohort consists of two parts: dose exploration (Part A) and efficacy exploration (Part B). Cohort A will be initiated first. The Safety Monitoring Committee (SMC) will conduct a comprehensive review and assessment based on the safety data from Cohort A, incorporating all available pharmacokinetic (PK) and preliminary efficacy data. Based on the SMC's recommendations, the study team will determine the timing for sequential initiation of Cohorts B and C.\n\nPart A of Cohort A uses a randomized, open-label design. Twelve patients with relapsed or refractory MCL will initially be enrolled and randomized 1:1 to two different TT-01488 tablet dose groups, receiving TT-01488 tablets plus rituximab 375 mg\u002Fm². Part B uses a Simon two-stage design, enrolling treatment-naïve MCL patients to receive TT-01488 at the recommended phase 2 dose (RP2D) plus rituximab 375 mg\u002Fm².",[56,63,67,72,75,79],{"label":57,"type":58,"description":59,"interventionNames":60},"Combination Cohort A, Part A dose evaluation","EXPERIMENTAL","Combination dose evaluation and RP2D determination ; Two dose levels of TT-01488 to be evaluated; R\u002FR MCL participants will be enrolled.",[61,62],"Drug: TT-01488 Tablets","Drug: Rituximab",{"label":64,"type":58,"description":65,"interventionNames":66},"Combination Cohort A, Part B efficacy evaluation","Participants with treatment-naive mantle cell lymphoma (MCL).",[61,62],{"label":68,"type":58,"description":69,"interventionNames":70},"Combination Cohort B, Part A dose evaluation","Combination dose evaluation and RP2D determination; R\u002FR MCL participants will be enrolled.",[61,62,71],"Drug: Immunomodulatory Agent",{"label":73,"type":58,"description":65,"interventionNames":74},"Combination Cohort B, Part B efficacy evaluation",[61,62,71],{"label":76,"type":58,"description":69,"interventionNames":77},"Experimental: Combination Cohort C, Part A dose evaluation",[61,62,78],"Drug: BCL2 Inhibitor",{"label":80,"type":58,"description":65,"interventionNames":81},"Experimental: Combination Cohort C, Part B dose evaluation",[61,62,78],[83,88,92,95],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":11},"DRUG","TT-01488 Tablets","Oral",[57,64,68,73,76,80],{"type":84,"name":89,"description":90,"armGroupLabels":91,"otherNames":11},"Rituximab","Intravenous Injection (IV)",[57,64,68,73,76,80],{"type":84,"name":93,"description":86,"armGroupLabels":94,"otherNames":11},"Immunomodulatory Agent",[68,73],{"type":84,"name":96,"description":86,"armGroupLabels":97,"otherNames":11},"BCL2 Inhibitor",[76,80],[99],{"name":100,"role":101,"phone":102,"phoneExt":11,"email":103},"Caixia Sun","CONTACT","025-58216298","clinicaltrial@transtherabio.com",[105,123],{"facility":106,"status":11,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510000","China","CN",{"type":113,"coordinates":114},"Point",[115,116],113.25,23.11667,{"lat":116,"lon":115},[119],{"name":120,"role":101,"phone":121,"phoneExt":11,"email":122},"Qingqing Cai","13798101121","caiqq@sysucc.org.cn",{"facility":124,"status":11,"city":125,"state":126,"zip":11,"country":110,"countryCode":111,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality",{"type":113,"coordinates":128},[129,130],121.45806,31.22222,{"lat":130,"lon":129},[133],{"name":134,"role":101,"phone":135,"phoneExt":11,"email":136},"Rong Tao","18121293435","hkutao@hotmail.com",{"type":138,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658768","phase-2-a-phase-ii-study-of-tt-01488-tablets-in-combination-with-anti-cd20-monoclonal-antibody-therapy-in-patients-with-mantle-cell-lymphoma-100658768",false,"NCT07855016","A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma","A Multicenter, Open-Label, Phase II Dose-Exploration and Expansion Study to Evaluate TT-01488 Tablets in Combination With an Anti-CD20 Monoclonal Antibody-Containing Regimen for the Treatment of Mantle Cell Lymphoma.","Inclusion Criteria:\n\n* Combination Cohort A: Part A (dose exploration): Age ≥18 years; no requirement for transplant ineligibility. Part B (efficacy exploration): Age ≥65 years, or 60 to \\\u003C65 years with ≥1 of the following criteria for autologous stem cell transplantation (auto-SCT) ineligibility:① left ventricular ejection fraction (LVEF) ≤45%;② creatinine clearance (CrCl) 30-\\\u003C70 mL\u002Fmin;③ diffusing capacity of the lung for carbon monoxide (DLCO) ≤60% predicted;④ Eastern Cooperative Oncology Group performance status (ECOG PS) 2;⑤ cumulative illness rating scale (CIRS) total score \\>6;⑥ other comorbidities precluding intensive induction chemotherapy and transplantation, as assessed by the investigator;\n* Combination Cohorts B and C: Age ≥18 years;\n* Histologically confirmed MCL, CD20-positive, with documented high Cyclin D1 expression by immunohistochemistry (IHC) and\u002For positive t(11;14) by cytogenetics;\n* Ann Arbor clinical stage II-IV;\n* Part A (Dose exploration): ≥1 prior line of therapy, relapsed\u002Frefractory disease, no prior BTK inhibitor, and ≤3 total prior lines.Part B (Efficacy exploration): No prior systemic therapy for MCL;\n* At least one measurable lesion;\n* ECOG performance status 0-2;\n* Adequate organ function within 7 days before first dose;\n* Women of childbearing potential: negative pregnancy test before treatment and effective contraception during the study and for 6 months after the last dose; male participants: effective contraception during the same period;\n* Written informed consent obtained before study participation.\n\nExclusion Criteria:\n\n* Participants whose treatment intent is tumor debulking prior to stem cell transplantation;\n* Active central nervous system (CNS) involvement by lymphoma, leptomeningeal disease, or history of spinal cord compression;\n* Severe cardiovascular disease within 6 months prior to screening;\n* Any active major infection (e.g., bacterial, viral, or fungal), including CMV DNA PCR-positive participants;\n* Serological evidence of active hepatitis B or hepatitis C infection;\n* Known history of human immunodeficiency virus (HIV) infection;\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug;\n* History of bleeding diathesis (e.g., hemophilia, von Willebrand disease); requiring or currently receiving anticoagulation with warfarin or equivalent vitamin K antagonists;\n* Requires strong CYP3A4 inhibitors or inducers. Strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 3 weeks before first dose of study drug are prohibited;\n* Concurrent or prior malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancers with no disease progression for ≥2 years;\n* Malabsorption syndrome or significant gastrointestinal dysfunction (e.g., gastrectomy, small bowel resection, symptomatic inflammatory bowel disease, complete\u002Fincomplete intestinal obstruction).","ALL","18 Years",{"count":149,"type":150},188,"ESTIMATED","INTERVENTIONAL",[153],"PHASE2","This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).",[156],"Mantle Cell Lymphoma (MCL)","NOT_YET_RECRUITING","2026-09-28",{"date":160,"type":161},"2026-10-02","ACTUAL",{"date":163,"type":150},"2026-10-10",{"date":165,"type":150},"2029-10-10",{"name":5,"class":6},2]