[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567281":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":42,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Cohort","EXPERIMENTAL","EBV immunological agent administration on day 0,7,14,21 and 42 for Intradermal or Subcutaneous Injection",[13],"Biological: EBV immunological agent",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","EBV immunological agent","27 participants with will be enrolled in the study and divided into three groups, including EBV-LPD (Adults group), EBV-LPD (Children group) and PTLD (Adults group） each with 9 people.The participants will be divided into three different dose groups, and a \"3+3\" dose escalation design is used. The low dose is 5.0×10\\^5, the medium dose is 2.0×10\\^6 and the high dose is 5.0×10\\^6 for children and low dose is 5.0×10\\^6, the medium dose is 2.0×10\\^7 and the high dose is 5.0×10\\^7 for adults. Only one dose will be administered to each participant with EBV immunological agent combined with Toripalimab 240mg.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xingchen Peng","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+86 18980606753","pxx2014@163.com",[31],{"facility":5,"status":20,"city":32,"state":33,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"Chengdu","Sichuan","China","CN",{"type":37,"coordinates":38},"Point",[39,40],104.06667,30.66667,{"lat":40,"lon":39},{"type":24,"investigatorFullName":23,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"professor","100567281","phase-1-clinical-study-of-therapeutic-immunological-agent-for-ebv-lymphoproliferative-diseases-100567281",false,"NCT06666153","Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases","A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases","Inclusion Criteria:\n\n1. For CAEBV patients and others with EBV-LPD 1). Patients who have signed informed consent before the trial and have a full understanding of the trial content, process and possible adverse reactions, and can complete the study according to the requirements of the trial protocol; 2). Patients with evidence consistent with the following diagnoses:\n\n   a. Patients with the 2016 version of WHO's CAEBV diagnostic criteria (except\n\n   B-lymphocyte involvement only) :\n   * Persistent or recurrent infectious IM-like symptoms lasting for more than 3 months;\n\n     * Increased EBV-DNA load in peripheral blood or tissue lesions: the level of EBV-DNA in peripheral blood was higher than 10\\^2.5 copies\u002Fμg DNA; ③ EBV-infected T cells or NK cells were found in the affected tissues or peripheral blood;\n\n       ④ Exclude other possible diagnoses, such as primary EBV infection (IM), autoimmune diseases, neoplastic diseases, other viral infections (HBV, HIV, HCV, etc.), and congenital or secondary immunodeficiency diseases; Or b. EBV-PLD patients with evidence consistent with pathological diagnosis of EBV antigen positive; 3). Male and female, 2-70 years old (including the critical value); 4). Patients with EBV-DNA≥1000 copies\u002FmL or EBER+; 5). Before the study, total bilirubin ≤ 2 times of the upper limit of normal value, blood creatinine ≤ 1.5 times of normal value; Fibrinogen can be corrected to ≥0.6g\u002FL after infusion.\n\n       6). Before the study, hemoglobin ≥60g\u002FL, platelets ≥50×10\\^9\u002FL, neutrophil count ≥1×10\\^9\u002FL; 7). Echocardiography showed LVEF ≥ 50%; 8). Women of childbearing age must confirm through a pregnancy test that they are not pregnant and be willing to use effective contraception during the test period and for ≥12 months after the last dose; 9). The compliance was good, and the patients and their families were willing to cooperate with the later follow-up.\n2. For PTLD patients 1). Patients who have signed informed consent before the trial and have a full understanding of the trial content, process and possible adverse reactions, and can complete the study according to the requirements of the trial protocol; 2). Patients diagnosed with PTLD WHO have received SOT or HSCT (refer to WHO 2016 diagnostic criteria); 3). Male and female, 18-70 years old (including the critical value); 4). Patients with EBV-DNA≥1000 copies\u002FmL or EBER+; 5). Women of childbearing age must confirm through a pregnancy test that they are not pregnant and be willing to use effective contraception during the test period and for ≥12 months after the last dose; 6). Good compliance, patients and their families are willing to cooperate with later follow-up.\n\nExclusion Criteria:\n\nPatients were excluded if they met any of the following criteria:\n\n1. For CAEBV patients and others with EBV-LPD 1). Participated in other drug clinical trials within 4 weeks; 2). Pregnant or lactating patients; 3). Patients with severe heart, lung and kidney diseases; 4). Active gastrointestinal bleeding; 5). The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ Grade 2 of NCI-CTC, 3rd edition); Have a history of herpes simplex, herpes zoster or chickenpox within 3 months; 6). People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 7). The subject has any active autoimmune disease or history of autoimmune disease; 8). In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.\n2. For PTLD patients 1). Patients with active aGVHD III-IV and\u002For mild and severe cGVHD; 2). Had received other cellular immunotherapy clinical studies 30 days before enrollment; 3). Pregnant or lactating patients; 4). Intracranial hypertension or confusion; Respiratory failure; Patients with diffuse intravascular coagulation; 5). Organ failure patients: (1) Heart :NYHA level IV cardiac function; (2) Liver: Grade C, reaching the Child-Turcotte liver function grade; (3) Kidney: renal failure, uremia; (4) Lungs: symptoms of respiratory failure. 6). Patients with active gastrointestinal bleeding; 7). Patients with severe non-compensatory hypertension; 8). Patients with severe non-compensatory diabetes; 9). The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ Grade 2 of NCI-CTC, 3rd edition); Have a history of herpes simplex, herpes zoster or chickenpox within 3 months; 10). Those who have a history of psychotropic drug abuse and cannot quit or those with mental disorders; 11). The subject has any active autoimmune disease or history of autoimmune disease; 12). Other possible diagnoses, such as primary EBV infection (IM), neoplastic diseases, other viral infections (HBV, HIV, HCV, etc.), and congenital or secondary immunodeficiency diseases; 13). According to the judgment of the investigator, there is a serious harm to the safety of the patient or affect the completion of the study.","ALL","2 Years","70 Years",{"count":55,"type":56},27,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","This study intends to conduct a prospective single-center open single-arm multi-dose escalation study on therapeutic immunological agent treatment in patients with Lymphoproliferative disease associated with EBV to observe the safety and efficacy.",[62,63],"CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome","PTLDs",[65,66,67,68,69],"EBV","immunotherapy","Lymphoproliferative disease, LPD","chronic active Epstein-Barr virus disease，CAEBV","Post-transplant lymphoproliferative disorders，PTLD","NOT_YET_RECRUITING","2024-10-28",{"date":73,"type":74},"2024-10-30","ACTUAL",{"date":76,"type":56},"2024-10",{"date":78,"type":56},"2026-12",{"name":5,"class":6},1]