[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457607":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAA-T Infusion","EXPERIMENTAL","Treatment with partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation.",[13],"Biological: Tumor-associated antigen-specific T cell (TAA-T)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Tumor-associated antigen-specific T cell (TAA-T)","Patients will receive cells due to the presence of refractory disease, or high risk for disease relapse and\u002For minimal residual detectable disease following conventional therapy. The treatment schedule is as follows: Patients will receive an infusion of partially HLA-matched TAA-T any time \\>1 week after completing most recent course of conventional (noninvestigational) therapy for their disease. For patients enrolled to DL2 or DL3, they will receive protocol-described lymphodepletion (LD) chemotherapy (fludarabine and cyclophosphamide) \\>2 weeks from most recent course of conventional therapy and post nadir and recovery from the prior therapy. Patients will be enrolled to one of the following TAA-T dose levels:\n\nBSA \\\u003C1.20 Dose Level 2 (+\u002F- ablation + low dose TAA-T cells) 2x10\\^7 Dose Level 3 (+\u002F- ablation + high dose TAA-T cells) 4x10\\^7\n\nBSA\\>=1.20 Dose Level 2 (+\u002F- ablation + low dose TAA-T cells) 4x10\\^7 Dose Level 3 (+\u002F- ablation + high dose TAA-T cells) 8x10\\^7",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Amy Hont, MD","CONTACT","202-476-3887","ahoughte@childrensnational.org",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Fahmida Hoq, MBBS","202-476-3634","fhoq@childrensnational.org",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-77.03637,38.89511,{"lat":44,"lon":43},[47,49],{"name":48,"role":24,"phone":25,"phoneExt":20,"email":26},"Amy Hont, MBBS, MS",{"name":23,"role":50,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"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","ATTACK","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* Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease.\n* Age \\>= 1 year and \\\u003C70 years\n* Patient or parent\u002Fguardian capable of providing informed consent.\n* No systemic corticosteroid exposure within 1 week of initiating protocol treatment.\n* Karnofsky\u002FLansky score of ≥50%.\n* For participant with history of total body irradiation (TBI), radiation to thorax, or treatment with cardiotoxic chemotherapy (anthracycline or equivalent): Left ventricular ejection fraction (LVEF) \\>50% OR left ventricular fractional shortening (FS) \\>27% (may be performed within the last 12 months, and after completion of such treatment\u002Fs)\n* Hemoglobin \\>7.0 g\u002FdL (level can be achieved with transfusion).\n* Direct bilirubin ≤2.5 mg\u002FdL or 3x ULN (whichever is higher).\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* Respiratory rate:\n* \\\u003C30 breaths per minute for patients aged \\\u003C18 years\n* \\\u003C25 breaths per minute for patients aged ≥18 years\n* Respiratory rate may be repeated if initial value is thought to be temporarily abnormal. If repeated, 2 values should be obtained ≥30 minutes apart prior to protocol treatment to be eligible.\n* Twelve (12) weeks post last radiation dose to the mediastinum\u002Fchest with resolution of any respiratory symptoms.\n* Negative pregnancy test in female patient of childbearing potential.\n* Agree to use contraceptive measures during study protocol participation through 6 months post final TAAT infusion (for FOCBP).\n* Prior to cycle #1 only (requisite for receiving lymphodepleting chemotherapy):\n* Absolute neutrophil count (ANC) \\>1000 \u002Ful.\n* Platelet count \\>75,000 \u002Ful.\n\nExclusion Criteria:\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* For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to protocol treatment.\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 initiating protocol treatment.\n* Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to initiating protocol treatment.\n* Exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to initiating protocol treatment.\n* Pregnant or lactating females.","ALL","1 Year","70 Years",{"count":66,"type":67},24,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is an open-label 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 following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and\u002For minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).",[73],"Solid Tumor","2026-07-31",{"date":76,"type":77},"2026-08-04","ACTUAL",{"date":79,"type":77},"2021-11-17",{"date":81,"type":67},"2029-10",{"name":5,"class":6},1]