[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535482":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":36,"locations":46,"responsibleParty":75,"collaborators":28,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":28,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":28,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":48,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level -1","EXPERIMENTAL","EGFR+ T Cell Dose (Day 0) 5 x 10\\^6 cells",[13],"Biological: CMV\u002FHIV-CAR T Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Level +1","EGFR+ T Cell Dose (Day 0) 25 x 10\\^6 cells",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Level +2","EGFR+ T Cell Dose (Day 0) 50 x 10\\^6 cells",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","CMV\u002FHIV-CAR T Cells","Eligible participants will temporarily interrupt their ART regimen for 4 days prior to leukapheresis to prevent residual cell drug levels that could inhibit lentiviral transduction of the T cells during CAR T cewll manufacturing. Participants will resume their ART regimen immediately after leukapheresis. Once the final cell product is released, participants will receive a single intravenous (IV)infusion of autologous CMV\u002FHIV-CAT T cells (defined as Day 0). Up to three doses of CMV\u002FHIV-CAR T cewlls may be explored.",[15,19,9],null,[30,33],{"name":31,"affiliation":5,"role":32},"John H. Baird, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"David (Davey) Smith, MD","UCSD, San Diego Center for AIDS Research",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":28,"email":41},"Marvin Hanashiro","CONTACT","(619) 543-3740","mhanashiro@health.ucsd.edu",{"name":43,"role":39,"phone":44,"phoneExt":28,"email":45},"Steven Hendrickx","(619) 543-6968","smhendrickx@health.ucsd.edu",[47,62],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Duarte","California","91010","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-117.97729,34.13945,{"lat":58,"lon":57},[61],{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"facility":63,"status":48,"city":64,"state":50,"zip":65,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"UCSD, Division of Infectious Diseases and Global Public Health","San Diego","92093",{"type":55,"coordinates":67},[68,69],-117.16472,32.71571,{"lat":69,"lon":68},[72,74],{"name":73,"role":39,"phone":28,"phoneExt":28,"email":28},"David Smith, MD",{"name":73,"role":32,"phone":28,"phoneExt":28,"email":28},{"type":76,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100535482","early-phase-1-cmv-specific-hiv-car-t-cells-as-immunotherapy-for-hivaids-100535482",false,"NCT06252402","CMV-specific HIV-CAR T Cells as Immunotherapy for HIV\u002FAIDS","A Pilot Study to Evaluate the Feasibility and Safety of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV-HIV CAR) T Cells in People Living With HIV","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age at the time of screening;\n* Karnofsky Performance Status (KPS) ≥ 70;\n* Documented HIV-1 infection anytime prior to study entry.;\n* On stable ART with undetectable HIV-1 RNA (i.e \\\u003C 20 copies \u002FmL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies\u002FmL are allowable);\n* CD4+ cell count ≥ 450 cells\u002FμL;\n* Adequate organ function;\n* Willingness to interrupt ART regimen for 4 days prior to leukapheresis;\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Concurrent illness or comorbid condition;\n* History of resistance to two or more classes of antiretroviral drugs;\n* History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.",true,"ALL","18 Years",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[92],"EARLY_PHASE1","Human immunodeficiency virus type 1 (HIV-1) causes a persistent infection that ultimately leads to acquired immunodeficiency syndrome (AIDS). Treatment of HIV-1 infection with combination anti-retroviral therapy (ART) suppresses HIV-1 replication to undetectable viral levels and saves lives. Nevertheless, ART cannot eradicate latent cellular reservoirs of the virus, and HIV-1 infection remains a life-long battle. Adoptive cellular immunotherapy using chimeric antigen receptor (CAR) engineered T cells directed against HIV-1 envelope subunit protein gp120 (HIVCAR T cells) may provide a safe and effective way to eliminate HIV-infected cells.\n\nHowever, the number of HIV-infected cells is low in participants under ART, and CAR T cells disappear if they are not stimulated by their target antigens. Interestingly, about 95% of HIV-1-infected individuals are CMV-seropositive and CMV-specific T cells have been shown to persist. To overcome the CAR T cells low persistence issue, we propose to make HIV-CAR T cells using autologous cytomegalovirus (CMV)-specific T cells, which can be stimulated by endogenous CMV in vivo. The overall hypothesis of this first-in-human Phase 1, open-label, single-arm study is that endogenous immune signals to CMV-specific T cells can maintain the presence of autologous bispecific CMV\u002FHIV-CAR T cells in healthy people living with HIV-1 (PLWH), and achieve long-term remission in the presence of ART.",[95],"HIV-1",[97,98],"HIV-1, PLWH (Healthy People Living with HIV-1) autologus","CMV-specific T cells, anti-retroviral therapy (ART), Immunotherapy","2026-02-20",{"date":101,"type":102},"2026-02-23","ACTUAL",{"date":104,"type":102},"2024-12-19",{"date":106,"type":89},"2026-12-11",{"name":5,"class":6},2]