[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484400":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":26,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T","EXPERIMENTAL","Target A positivity was assigned to CAR-T cell therapy.",[13,14],"Behavioral: PK Blood Collection","Drug: CAR",{"label":16,"type":10,"description":17,"interventionNames":18},"TCR-T","Target A negative, Target B positive and Target C positive were assigned to TCR-T cell treatment group.",[13,19],"Drug: TCR",[21,27,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","PK Blood Collection","All subjects were subjected to PK blood sampling as prescribed by the protocol.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","CAR","Target A positive subjects will receive CAR-T cell therapy.",[9],[33],"CAR-T cell therapy",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"TCR","Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.",[16],[39],"TCR -T cell therapy",[41],{"name":42,"affiliation":5,"role":43},"Dongmei Ji, Doctorate","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":26,"email":48},"CONTACT","13564183928","jidongmei2000@hotmail.com",[50],{"facility":5,"status":51,"city":52,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Shanghai","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62,64],{"name":63,"role":46,"phone":47,"phoneExt":26,"email":48},"Dongmei Ji, doctor",{"name":63,"role":43,"phone":26,"phoneExt":26,"email":26},{"type":43,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ji Dongmei","Chief Doctor","100484400","early-phase-1-clinical-study-on-the-ebv-car-t-tcr-t-cells-in-the-treatment-of-nasopharyngeal-carcinoma-100484400",false,"NCT05587543","Clinical Study on the EBV CAR-T \u002FTCR-T Cells in the Treatment of Nasopharyngeal Carcinoma","Clinical Study on the Safety and Efficacy of EBV CAR-T \u002FTCR-T Cells in the Treatment of Recurrent \u002F Refractory EBV Positive Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Voluntary written informed consent;\n* Age ≥18 years old, ≤75 years old, male and female;\n* Expected survival ≥3 months;\n* The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0-2;\n* Ebv-positive nasopharyngeal carcinoma was diagnosed by in situ hybridization with Ebers (Eber-fish) .\n* Pathological Paraffin section testing (within 5 years before signing the informed consent form) ;\n* At least one measurable lesion according to RECIST v1.1 criteria for solid tumors;\n* Recurrent\u002Fmetastatic nasopharyngeal carcinoma patients who had previously failed second-line or more systemic therapy;\n* An apheresis or venous access can be established and there are no other contraindications to blood cell isolation；\n* CTCAE 5.0 was lower than grade 1 in the side effects of previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.)\n* During the study period and up to 6 months after the end of the administration, fertile subjects -LRB-both male and female) were required to use effective medical contraception. For women of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the results were negative.\n\nExclusion Criteria:\n\n* Active central nervous system metastases (except those that are stable after treatment)；\n* HIV positive, HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 CPS\u002Fml) , HCV antibody positive and HCV RNA positive;\n* Patients with mental or psychological disorders who can not cooperate with the treatment and evaluation of the curative effect;\n* Subjects with severe autoimmune disease and long-term use of immunosuppressants;\n* Active or uncontrolled infection requiring systemic therapy was present within 14 days prior to enrollment；\n* Any unstable systemic disease;\n* Complicated with dysfunction of important organs such as lung, brain and kidney.\n* Subjects had undergone major surgery or severe trauma within 4 weeks before receiving cell therapy, or were expected to undergo major surgery during the study period.\n* Participants received their last dose of radiation or anti-tumor therapy within 4 weeks of receiving the cell therapy.\n* Participants had or had had other cancers that were incurable for up to 3 years, except for cervical cancer in situ or skin basal-cell carcinoma, and other cancers that had disease-free survival of more than 5 years.\n* Treated with Chimeric antigen receptor t-cell therapy within six months.\n* Graft-versus-host disease (GVHD)；\n* Subjects who were receiving systemic steroid therapy before screening and who required long-term systemic steroid therapy during treatment as determined by the investigator (with the exception of inhaled or topical use) ; And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or topical use) .\n* Severe allergies or a history of allergies;\n* Subjects requiring anticoagulant therapy;\n* Pregnant or lactating women, or a six-month pregnancy plan (for both men and women)；\n* Researchers believe there are other reasons not to include people in treatment.","ALL","18 Years","75 Years",{"count":79,"type":80},24,"ESTIMATED","INTERVENTIONAL",[83],"EARLY_PHASE1","This study was a single-arm, open-label, \"3 + 3\" dose-escalation Exploratory research. The patients were divided into two groups: EBV TCR-T-cell Group and EBV CAR-T-cell group. The EBV CAR-T-treated group received three progressively increasing dose levels (3.0 × 106 cells\u002Fkg, 9.0 × 106 cells\u002Fkg, 1.5 × 107 cells\u002Fkg) of EBV CAR-T-cell therapy; The EBV TCR-T-cell group received three progressively increasing doses (5.0 × 106 cells\u002Fkg, 1.5 × 107 cells\u002Fkg, 3.0 × 107 cells\u002Fkg) of EBV TCR-T-cell therapy.",[86],"Nasopharyngeal Carcinoma","2026-03-28",{"date":89,"type":90},"2026-04-02","ACTUAL",{"date":92,"type":90},"2022-12-28",{"date":94,"type":80},"2030-10",{"name":5,"class":6},1]