[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640480":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":52,"locations":61,"responsibleParty":77,"collaborators":30,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":30,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":99,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15,16,17,18],"Drug: Rimegepant","Drug: Glofitamab","Drug: Obinutuzumab","Biological: CD19 CAR-T Cell Therapy","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":20,"type":21,"description":22,"interventionNames":23},"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.",[14,15,16,17,18],[25,31,35,39,44,48],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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.",[20,9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Obinutuzumab","Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.",[20,9],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":30},"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.",[20,9],{"type":26,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Fludarabine","Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.",[20,9],{"type":26,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"Cyclophosphamide","Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.",[20,9],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"Weili Zhao","CONTACT","+862164370045 Ext. 610707","zwl_trial@163.com",{"name":59,"role":55,"phone":56,"phoneExt":30,"email":60},"Rong Shen","rongshen510@yeah.net",[62],{"facility":63,"status":30,"city":64,"state":65,"zip":66,"country":65,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","China","200020","CN",{"type":69,"coordinates":70},"Point",[71,72],121.45806,31.22222,{"lat":72,"lon":71},[75],{"name":54,"role":55,"phone":76,"phoneExt":30,"email":57},"64370045",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"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":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98],"Relapsed\u002FRefractory Large B-cell Lymphoma (LBCL)","NOT_YET_RECRUITING","2026-05-23",{"date":102,"type":103},"2026-05-29","ACTUAL",{"date":105,"type":92},"2026-05",{"date":107,"type":92},"2029-04",{"name":5,"class":6},1]