[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100298003":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":76,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shenzhen Geno-Immune Medical Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infusion of pathogen-specific CTLs","EXPERIMENTAL","Repetitive CTL infusions to treat microbial infections",[13],"Biological: pathogen-specific CTLs",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","pathogen-specific CTLs","Patients will receive approximately 1x10\\^5\\~1x10\\^6 CTLs\u002Fkg as a single infusion via IV injection and may receive additional infusions.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Lung-Ji Chang, PhD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+86 0755-86573763","c@szgimi.org",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Shenzhen Geno-immune Medical Institute","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],114.0683,22.54554,{"lat":43,"lon":42},[46],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":24,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Lung-Ji Chang","President","100298003","phase-1-antigen-specific-cytotoxic-t-cells-in-the-treatment-of-opportunistic-infections-100298003",false,"NCT03159364","Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Phase I\u002FII Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Inclusion Criteria:\n\nSubjects with or without hematopoietic stem cell transplantation \u002F organ transplant recipients need to meet the following conditions:\n\n* Evidence of CMV, EBV, ADV, BKV or known pathogen infection (viral DNA, immunohistochemical cytology positive); contraindications or invalid to anti-microbial drugs.\n* Subjects with virus DNA increased in the 2 consecutive peripheral blood samples (≥ 1000 genomic copies\u002Fml blood) at least 24 hours apart.\n* Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 0.5x109 \u002F L, platelet (PLT) ≥ 20x109 \u002F L.\n* Patients with pahogen disease (organ\u002F tissue infiltration) symptoms, fever, diarrhea, or lymphadenopathy, regardless of the level of peripheral blood virus DNA, and confirmed by the presence of viral DNA or microbial antigens within body fluid or biopsy.\n* The subject \u002F guardian has signed a written consent form before any trial begins.\n\nProper renal and hepatic functions (ULN denotes \"upper limit of normal range\"):\n\n* Creatinine ≤ 2\\*ULN.\n* Bilirubin ≤ 2\\*ULN.\n* SGOT ≤ 3\\*ULN.\n* SGPT≤ 3\\*ULN.\n\nIf CTL is not from the patient's own, then the provider of CTLs needs to meet the following criteria:\n\n* Did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n* White blood cells ≥ 3,500 \u002F μl, lymphocytes ≥ 750 \u002F μl.\n* Obtain a signed informed consent from the patient and \u002F or the guardian or the donor of the BMT recipient.\n* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative.\n* Physical examination in line with the standard of healthy blood donors.\n\nExclusion Criteria:\n\n* Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\n* GVHD (graft-versus-host disease) performance score at II-IV.\n* Subject is albumin-intolerant.\n* Subject with life expectancy less than 4 weeks.\n* Subject participated in other investigational somatic cell therapies within past 30 days.\n* Subject with positive pregnancy test result.","ALL","6 Months","80 Years",{"count":61,"type":62},100,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.",[69,70,71,72,73,74,75],"Pathogen Infection","EBV Infection","CMV Infection","Adenovirus Infection","BKV Infection","Fungus Infection","Tuberculosis",[77,78,79,80],"CTL","Virus CTL","Fungus CTL","TB CTL","2026-06-18",{"date":83,"type":84},"2026-06-22","ACTUAL",{"date":86,"type":84},"2026-06-01",{"date":88,"type":62},"2030-12-31",{"name":5,"class":6},1]