[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-large-b-cell-lymphoma-lbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-large-b-cell-lymphoma-lbcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100653593","phase-1-a-phase-ibii-exploratory-clinical-trial-of-memory-enhanced-719-themis-car-t-cell-therapy-for-relapsedrefractory-large-b-cell-lymphoma-100653593",false,"NCT07788118","A Phase Ib\u002FII Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase Ib\u002FII Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed\u002FRefractory Large B-Cell Lymphoma: A Single-Arm Design Using a Historical Control (7×19 CAR-T)","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form.\n2. Age range: 18 - 75 years old. Gender is not restricted.\n3. Histologically confirmed large B-cell lymphoma, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), and mantle cell lymphoma (MCL).\n4. CD19-positive (as determined by immunohistochemistry or flow cytometry; based on the most recent tumor biopsy results).\n5. Definition of relapsed\u002Frefractory: Failure to achieve complete remission (CR) after at least two lines of therapy (which must include a CD20 monoclonal antibody and an anthracycline); or disease progression during any course of treatment; or relapse\u002Fprogression within 12 months after autologous hematopoietic stem cell transplantation.\n6. At least one measurable lesion: any lymph node lesion with a longest dimension \\>1.5 cm, or any extranodal lesion with a longest dimension \\>1.0 cm, and the lesion shows uptake on PET-CT (SUV greater than the hepatic pool).\n7. Absolute neutrophil count in peripheral blood ≥ 1,000\u002FμL; platelet count ≥ 45,000\u002FμL.\n8. Cardiac, hepatic, and renal function: creatinine \\\u003C 1.5 mg\u002FdL; ALT\u002FAST ≤ 2.5 times the upper limit of normal; total bilirubin \\\u003C 1.5 mg\u002FdL; ejection fraction ≥ 50%.\n9. Possess sufficient cognitive capacity to voluntarily sign the informed consent form.\n10. Participants of reproductive potential must be willing to use effective contraception (from the time of signing the informed consent form until 12 months after CAR-T infusion).\n11. The investigator estimates a life expectancy of at least 4 months.\n12. Willing to comply with the schedule of visits, dosing regimen, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. History of other malignant tumors (excluding cured basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc.).\n2. Autologous hematopoietic stem cell transplantation within the past 6 weeks.\n3. Any targeted CAR-T therapy within 3 months prior to this CAR-T treatment.\n4. Patients who have previously received PD-1 monoclonal antibodies must have a washout period of ≥3 months before enrollment.\n5. Received cytotoxic drugs, glucocorticoids (except for prednisone-equivalent doses of ≤10 mg\u002Fday), or other targeted therapies within 2 weeks prior to cell collection.\n6. Active autoimmune diseases (e.g., systemic lupus erythematosus, inflammatory bowel disease, etc.).\n7. Uncontrolled active bacterial, fungal, or viral infections.\n8. HIV infection, syphilis; active hepatitis B or C: Hepatitis B: HBsAg-positive and HBV-DNA ≥ 1,000 IU\u002FmL; Hepatitis C: HCV RNA-positive and abnormal liver function.\n9. Known central nervous system lymphoma (confirmed by brain MRI or CT and cerebrospinal fluid examination).","ALL","18 Years","75 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).",[28,29,30,31,32],"Relapsed\u002FRefractory Large B-cell Lymphoma (LBCL)","Diffuse Large B-Cell Lymphoma (DLBCL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Transforming Follicular Lymphoma (tFL)","Mantle Cell Lymphoma (MCL)","RECRUITING","2026-08-23",{"date":36,"type":37},"2026-08-26","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2031-09-01",{"name":43,"class":44},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100640480","phase-2-rimegepant-plus-glofitamab-and-cd19-car-t-therapy-in-rr-lbcl-100640480","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.",{"count":54,"type":21},100,[25],"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.",[28],"NOT_YET_RECRUITING","2026-05-23",{"date":61,"type":37},"2026-05-29",{"date":63,"type":21},"2026-05",{"date":65,"type":21},"2029-04",{"name":67,"class":44},"Ruijin Hospital"]