[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640480":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":45,"interventions":62,"overallOfficials":38,"centralContacts":89,"locations":98,"responsibleParty":114,"collaborators":38,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":38,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":38,"enrollmentInfo":127,"targetDuration":38,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":38,"overallStatus":136,"whyStopped":38,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Complete Response Rate at 6 Months","Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion.","6 months after CAR-T cell infusion",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate","Objective response rate is defined as the proportion of participants who achieve complete response or partial response.","Up to 24 months",{"measure":19,"description":20,"timeFrame":21},"Complete Response Rate at Day 28","Complete response rate at Day 28 is defined as the proportion of participants who achieve complete response at Day 28 after CAR-T cell infusion.","Day 28 after CAR-T cell infusion",{"measure":23,"description":24,"timeFrame":25},"Complete Response Rate at 3 Months","Complete response rate at 3 months is defined as the proportion of participants who achieve complete response at 3 months after CAR-T cell infusion.","3 months after CAR-T cell infusion",{"measure":27,"description":28,"timeFrame":17},"Progression-Free Survival","Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.",{"measure":30,"description":31,"timeFrame":17},"Duration of Response","Duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.",{"measure":33,"description":34,"timeFrame":17},"Overall Survival","Overall survival is defined as the time from randomization to death from any cause.",{"measure":36,"description":37,"timeFrame":17},"Adverse Events","Incidence and severity of adverse events will be assessed throughout the study.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE",[46,57],{"label":47,"type":48,"description":49,"interventionNames":50},"Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy","EXPERIMENTAL","Participants will receive rimegepant in combination with glofitamab and CD19 CAR-T cell therapy. Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.",[51,52,53,54,55,56],"Drug: Rimegepant","Drug: Glofitamab","Drug: Obinutuzumab","Biological: CD19 CAR-T Cell Therapy","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":58,"type":59,"description":60,"interventionNames":61},"Glofitamab Plus CD19 CAR-T Cell Therapy","ACTIVE_COMPARATOR","Participants will receive glofitamab in combination with CD19 CAR-T cell therapy. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.",[52,53,54,55,56],[63,68,72,76,81,85],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":38},"DRUG","Rimegepant","Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.",[47],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":38},"Glofitamab","Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.",[58,47],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":38},"Obinutuzumab","Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.",[58,47],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":38},"BIOLOGICAL","CD19 CAR-T Cell Therapy","Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.",[58,47],{"type":64,"name":82,"description":83,"armGroupLabels":84,"otherNames":38},"Fludarabine","Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.",[58,47],{"type":64,"name":86,"description":87,"armGroupLabels":88,"otherNames":38},"Cyclophosphamide","Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.",[58,47],[90,95],{"name":91,"role":92,"phone":93,"phoneExt":38,"email":94},"Weili Zhao","CONTACT","+862164370045 Ext. 610707","zwl_trial@163.com",{"name":96,"role":92,"phone":93,"phoneExt":38,"email":97},"Rong Shen","rongshen510@yeah.net",[99],{"facility":100,"status":38,"city":101,"state":102,"zip":103,"country":102,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","China","200020","CN",{"type":106,"coordinates":107},"Point",[108,109],121.45806,31.22222,{"lat":109,"lon":108},[112],{"name":91,"role":92,"phone":113,"phoneExt":38,"email":94},"64370045",{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor and Director, Shanghai Institute of Hematology","100640480","phase-2-rimegepant-plus-glofitamab-and-cd19-car-t-therapy-in-rr-lbcl-100640480",false,"NCT07613788","Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R\u002FR LBCL","A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the written informed consent form.\n* Age 18 years or older.\n* Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression.\n* Relapsed or refractory disease after at least one prior line of systemic therapy.\n* Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody.\n* Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy.\n* Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality.\n* ECOG performance status of 0 to 2.\n* Life expectancy of at least 12 weeks.\n* Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator.\n* Participants of reproductive potential must agree to use effective contraception during the study period.\n* Able and willing to comply with the study protocol, in the investigator's judgment.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any study treatment or related compounds.\n* Active or uncontrolled infection requiring systemic treatment.\n* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Uncontrolled or clinically significant viral infection as defined by the protocol.\n* Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment.\n* Severe or uncontrolled cardiovascular disease.\n* Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment.\n* Known or suspected history of hemophagocytic lymphohistiocytosis.\n* Recent thromboembolic event before screening.\n* History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer.\n* Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment.\n* Pregnant or breastfeeding women, or participants planning pregnancy during the study period.\n* Concurrent participation in another interventional clinical trial.\n* Need for prohibited concomitant medications that cannot be discontinued or substituted.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.","ALL","18 Years",{"count":128,"type":129},100,"ESTIMATED","INTERVENTIONAL",[132],"PHASE2","This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed\u002Frefractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.",[135],"Relapsed\u002FRefractory Large B-cell Lymphoma (LBCL)","NOT_YET_RECRUITING","2026-05-23",{"date":139,"type":140},"2026-05-29","ACTUAL",{"date":142,"type":129},"2026-05",{"date":144,"type":129},"2029-04",{"name":5,"class":6},1]