[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457607":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":55,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A for patients age ≥18 years and \u003C70 years","EXPERIMENTAL","Arm A will enroll patients age ≥18 years and \\\u003C70 years. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety. Following demonstration of safety in dose level 1, lymphodepleting chemotherapy will be administered prior to the first dose of TAA-Ts on the dose escalation phase (dose levels 2 and 3). The TAA-T product will be assessed for safety and anti-tumor activity.",[13],"Biological: Tumor-associated antigen-specific T cell (TAA-T)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B for patients age ≥6 years and \u003C18 years","Arm B will enroll patients age ≥6 years and \\\u003C18 years. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety. Following demonstration of safety in dose level 1, lymphodepleting chemotherapy will be administered prior to the first dose of TAA-Ts on the dose escalation phase (dose levels 2 and 3). The TAA-T product will be assessed for safety and anti-tumor activity.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Tumor-associated antigen-specific T cell (TAA-T)","Patients will receive an infusion of partially HLA-matched TAA-T any time \\>1 week after completing most recent course of conventional (non-investigational) therapy for their disease. For the lymphodepletion cohort, patients will receive lymphodepletion (LD) chemotherapy \\>2 weeks from most recent course of conventional therapy and will nadir and recover before beginning TAA-T therapy. Patients will be enrolled to one of the following TAA-T dose levels:\n\nBSA \\\u003C1.20 BSA ≥1.20 Dose level 1 without LD (low dose) 2x107 cells 4x107 cells Dose level 2 (LD + Low dose) 2x107 cells 4x107 cells Dose level 3 (LD + High dose) 4x107 cells 8x107 cells",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Amy Hont, MD","CONTACT","202-476-3887","ahoughte@childrensnational.org",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Fahmida Hoq, MBBS","202-476-3634","fhoq@childrensnational.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-77.03637,38.89511,{"lat":48,"lon":47},[51,53],{"name":52,"role":28,"phone":29,"phoneExt":24,"email":30},"Amy Hont, MBBS, MS",{"name":27,"role":54,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Amy Hont","Oncologist","100457607","phase-1-multi-tumor-associated-antigen-specific-t-lymphocytes-to-treat-patients-with-high-risk-solid-tumors-100457607",false,"NCT05238792","Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors","Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors","Inclusion Criteria:\n\nPARTICIPANT INCLUSION CRITERIA\n\nRECIPIENT SCREENING INCLUSION CRITERIA\n\n* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.\n* HLA type and match through at least one allele with antigen-specific activity.\n* Refractory disease, residual detectable disease following conventional therapy or relapsed disease.\n* Arm A: age ≥18 years and \\\u003C70 years\n* Arm B: age ≥6 years to \\\u003C18 years\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nRECIPIENT INCLUSION CRITERIA FOR INITIAL TAA-T ADMINISTRATION AND FOR SUBSEQUENT INFUSION\n\n* No systemic steroid exposure within 1 week of TAA-T infusion.\n* Karnofsky\u002FLansky score of ≥50% (see Appendix 4).\n* Left ventricular ejection fraction (LVEF) \\>50% or left ventricular systolic dysfunction (LVSD) \\>27% if history of total body irradiation (TBI) (may be performed within the last 6 months).\n* Hemoglobin \\>7.0 g\u002FdL (level can be achieved with transfusion).\n* Bilirubin ≤2.5 mg\u002FdL.\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤5 x the upper limit of normal for age.\n* Serum creatinine \\\u003C1.0 mg\u002FdL or 2x the upper limit of normal for age (whichever is higher).\n* Pulse oximetry of \\>90% on room air.\n* Negative pregnancy test in female patient of childbearing age.\n* Agree to use contraceptive measures during study protocol participation (when age appropriate).\n* Patients receiving lymphodepleting chemotherapy must have:\n\n  * Absolute neutrophil count (ANC) \\>1000 \u002Ful.\n  * Platelet count \\>75,000 \u002Ful.\n\nExclusion Criteria:\n\nPARTICIPANT EXCLUSION CRITERIA RECIPIENT SCREENING EXCLUSION CRITERIA\n\n* Patients with known human immunodeficiency virus (HIV) infection.\n* Pregnant or lactating females.\n* Patients who have undergone previous allogeneic stem cell transplant.\n* Patients who have undergone previous autologous stem cell transplant within the past 60 days.\n\nRECIPIENT EXCLUSION CRITERIA FOR INITIAL AND SUBSEQUENT TAA-T INFUSION\n\n* Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n\n  * For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.\n  * For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.\n* Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to TAA-T infusion.\n* For patients receiving lymphodepleting chemotherapy: exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to treatment.\n* Pregnant or lactating females.","ALL","6 Years","70 Years",{"count":69,"type":70},36,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","This is a phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy for patients with high-risk solid tumors due to the presence of refractory, relapsed and\u002For minimal residual detectable disease following conventional therapy. Conventional therapy may include chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy.",[76],"Solid Tumor","2026-03-11",{"date":79,"type":80},"2026-03-12","ACTUAL",{"date":82,"type":80},"2021-11-17",{"date":84,"type":70},"2029-10",{"name":5,"class":6},1]