[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653593":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":71,"studyPopulation":71,"armGroups":75,"interventions":82,"overallOfficials":88,"centralContacts":92,"locations":101,"responsibleParty":119,"collaborators":71,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":71,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":71,"studyType":134,"phases":135,"briefSummary":138,"conditions":139,"keywords":71,"overallStatus":104,"whyStopped":71,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":51},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Determination of the Recommended Phase II Dose (RP2D)","Based on the incidence of DLTs, CAR-T cell kinetics, preliminary efficacy, and safety data from the Phase Ib dose-escalation phase, the Safety Review Committee (SRC) determined the RP2D following a comprehensive evaluation.","Up to 3 months",{"measure":14,"description":15,"timeFrame":12},"Objective Response Rate (ORR)","At 3 months (±7 days) after infusion, the proportion of patients achieving complete remission (CR) or partial remission (PR) was assessed according to the Lugano 2014 criteria, and a descriptive comparison was made with the historical control cohort.",{"measure":17,"description":18,"timeFrame":12},"Complete Remission Rate (CR Rate)","At 3 months (±7 days) after infusion, the proportion of patients who achieved complete remission (CR) was assessed according to the Lugano 2014 criteria, and a descriptive comparison was made with the historical control cohort.",[20,24,27,30,34,37,40,43,47],{"measure":21,"description":22,"timeFrame":23},"Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) graded according to ASTCT 2019 criteria","The incidence and severity of CRS and ICANS will be assessed according to the American Society for Transplantation and Cellular Therapy (ASTCT) 2019 consensus grading criteria. The incidence of each grade (Grades 1-4) will be summarized, with particular attention to the incidence of Grade ≥3 CRS and Grade ≥3 ICANS.","up to 28 days",{"measure":25,"description":26,"timeFrame":23},"Incidence and duration of Grade ≥3 hematologic toxicities assessed according to CTCAE version 5.0","The incidence and duration of Grade ≥3 neutropenia, anemia, and thrombocytopenia will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.",{"measure":28,"description":29,"timeFrame":23},"Incidence of clinically significant infections requiring anti-infective treatment or hospitalization","The incidence of bacterial, fungal, and viral infections requiring anti-infective treatment or hospitalization will be recorded and summarized.",{"measure":31,"description":32,"timeFrame":33},"Progression-Free Survival (PFS)","Progression-free survival is defined as the time from CAR-T cell infusion to the first documented disease progression (PD) or death from any cause, whichever occurs first. Median PFS and PFS rates at 12 and 24 months will be estimated using the Kaplan-Meier method.","up to 2-5 years",{"measure":35,"description":36,"timeFrame":33},"Overall Survival (OS)","Overall survival is defined as the time from CAR-T cell infusion to death from any cause. Median OS and OS rates at 12 and 24 months will be estimated using the Kaplan-Meier method.",{"measure":38,"description":39,"timeFrame":33},"Duration of Response (DOR)","Among participants who achieve complete response (CR) or partial response (PR), duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first. Median DOR will be estimated using the Kaplan-Meier method.",{"measure":41,"description":42,"timeFrame":33},"In Vivo Kinetics of CAR-T Cells","Measurement of CAR-T Cell Counts in Peripheral Blood and Comparison of Kinetic Parameters",{"measure":44,"description":45,"timeFrame":46},"Serum Cytokine Dynamics","Measure the concentrations of cytokines such as IL-6, IFN-γ, IL-7, and CCL19 in serum at various time points following infusion.","day-5,day4,day7,day11,day14,day18,day21,day28,month 3",{"measure":48,"description":49,"timeFrame":50},"B-Cell Recovery","Determine the absolute count of CD19+CD20+ cells in peripheral blood to assess the dynamics of B-cell recovery following infusion.","month1, month3, month6, month9, months12, month24, year3 and year5",[52,56,60,64],{"measure":53,"description":54,"timeFrame":55},"Single-Cell Functional Characterization of CAR-T Products","Detection of various cytokines secreted by CAR-T infusion products at the single-cell level upon stimulation with the CD19 antigen.","day-5, day4, day7, day11, day14, day18, day21, day28, month2",{"measure":57,"description":58,"timeFrame":59},"Spearman correlation between memory T-cell subset proportions in the CAR-T infusion product and 3-month complete response","The proportions of stem cell memory T cells (TSCM), central memory T cells (TCM), effector memory T cells (TEM), and terminal effector T cells (TTE) in the CAR-T infusion product will be measured by multicolor flow cytometry. T-cell subsets will be defined as TSCM (CD45RA+CCR7+CD95+), TCM (CD45RA-CCR7+), TEM (CD45RA-CCR7-), and TTE (CD45RA+CCR7-). The proportion of each subset will be expressed as the percentage of CAR-T cells. The correlation between memory T-cell subset proportions and complete response at 3 months will be assessed using Spearman rank correlation and exploratory group comparisons using the Mann-Whitney U test.","day-5, day4, day7, day11, day14, day18, day21, day28, month3",{"measure":61,"description":62,"timeFrame":63},"Trends in Anti-CAR Antibodies (ADA)","Determination of the Prevalence and Titer of Anti-FMC63 Antibodies (ADA) in Serum","day-5, day4, day7, day11, day14, day18, day21, day28, month3,month6,month12, year2 and year5",{"measure":65,"description":66,"timeFrame":67},"Area under the receiver operating characteristic curve (AUC) of peak serum cytokine and chemokine levels within 28 days after CAR-T infusion for discrimination of objective response","Peak serum concentrations of IL-7, CCL19, MIP-1α, MIP-1β, and SDF-1α during the first 28 days after CAR-T cell infusion will be measured using the protocol-specified serum cytokine\u002Fchemokine assay. Receiver operating characteristic (ROC) curve analysis will be performed to evaluate the ability of each biomarker to discriminate objective response, defined as complete response or partial response according to protocol-defined disease response criteria. The AUC and the optimal biomarker cutoff value will be determined for each biomarker.","month6, month12, year2, year5",{"allocation":69,"interventionModel":70,"interventionModelDescription":71,"primaryPurpose":72,"observationalModel":71,"timePerspective":71,"maskingInfo":73},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":74,"maskingDescription":71,"whoMasked":71},"NONE",[76],{"label":77,"type":78,"description":79,"interventionNames":80},"7×19-THEMIS CAR-T","EXPERIMENTAL","A single dose intravenous injection of 7X19-Themis at day 0",[81],"Biological: 7×19-THEMIS CAR-T cells",[83],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":71},"BIOLOGICAL","7×19-THEMIS CAR-T cells","IL7 and CCL19 Armed anti-CD19 CAR-T with coexpressing Themis",[77],[89],{"name":90,"affiliation":5,"role":91},"Wenbin Qian,Professor","STUDY_CHAIR",[93,97],{"name":90,"role":94,"phone":95,"phoneExt":71,"email":96},"CONTACT","+86 13605801032","qianwb@zju.edu.cn",{"name":98,"role":94,"phone":99,"phoneExt":71,"email":100},"Wen Lei,Doctor","+86 18258448016","leiwen2017@zju.edu.cn",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"The Second Affiliated Hospital,School of Medicine,Zhejiang University, Hangzhou, Zhejiang 310009","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":111,"coordinates":112},"Point",[113,114],120.16142,30.29365,{"lat":114,"lon":113},[117,118],{"name":90,"role":94,"phone":95,"phoneExt":71,"email":96},{"name":98,"role":94,"phone":99,"phoneExt":71,"email":100},{"type":120,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","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":132,"type":133},70,"ESTIMATED","INTERVENTIONAL",[136,137],"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).",[140,141,142,143,144],"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)","2026-08-23",{"date":147,"type":148},"2026-08-26","ACTUAL",{"date":150,"type":133},"2026-09-01",{"date":152,"type":133},"2031-09-01",{"name":5,"class":6},1]