[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606238":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":26,"locations":35,"responsibleParty":67,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":19,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":38,"whyStopped":19,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"This is single arm study.","EXPERIMENTAL","Lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine will be administered prior to CAR-TA T cell product infusion. The DNR-TA T cells and B7-H3 CAR T cells will be generated and combined into a final product comprised of the two T cell components combined at a 1:1 ratio.",[13],"Biological: Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells",[9],null,[21,24],{"name":22,"affiliation":5,"role":23},"Holly Meany, MD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":23},"Amy Hont, MD",[27,31],{"name":22,"role":28,"phone":29,"phoneExt":19,"email":30},"CONTACT","2024765697","HMeany@childrensnational.org",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Fahmida Hoq, MBBS","2024763634","FHoq@childrensnational.org",[36,57],{"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},[51,55],{"name":52,"role":28,"phone":53,"phoneExt":19,"email":54},"Fahmida Hoq, MBBS, MS","202-476-3634","FHOQ@childrensnational.org",{"name":25,"role":56,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"facility":58,"status":59,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Childrens National Hospital","NOT_YET_RECRUITING",{"type":45,"coordinates":61},[47,48],{"lat":48,"lon":47},[64,65,66],{"name":22,"role":28,"phone":29,"phoneExt":19,"email":30},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"name":25,"role":56,"phone":19,"phoneExt":19,"email":19},{"type":23,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"HMeany","Med Dir Solid Tumor Program",[71,74],{"name":72,"class":73},"National Cancer Institute (NCI)","NIH",{"name":75,"class":6},"Cancer Research UK","100606238","phase-1-selective-antigen-specific-t-cells-and-car-t-cells-in-subjects-with-relapsedrefractory-embryonal-tumors-sabre-100606238",false,"NCT07172958","Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","SABRE","Inclusion Criteria:\n\nRecipient Inclusion Criteria for Procurement:\n\n* Diagnosis of relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor\n* Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to unacceptable toxicity or contraindication\n* Measurable or evaluable disease by imaging, as determined following most recent therapy\n* Age ≥ 1 year and \\\u003C 24 years\n* Weight ≥ 10 kg\n* No systemic steroid exposure within 1 week of procurement\n* Karnofsky\u002FLansky score of ≥ 60 (See Appendix 3)\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs (as described in Appendix 5) during study protocol participation through 6 months following the administration of the CAR-TA T cells\n* ANC \\> 500\u002FµL\n* ALC \\> 1000\u002FµL\n* Platelet count \\> 50,000\u002FuL (level can be achieved with transfusion)\n* Bilirubin ≤ 2.5 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002FAlanine transaminase (ALT) ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1. to \\\u003C 2 years 0.6 0.6\n  2. to \\\u003C 6 years 0.8 0.8\n\n  6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Pulse oximetry of \\> 90% on room air\n* Adequate cardiac function defined as:\n\n  * Shortening fraction of ≥ 27% by echocardiogram, or\n  * Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram (i.e., MUGA).\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* The following time frames must have elapsed between prior therapy completion and apheresis cell collection:\n\n  * Myelosuppressive chemotherapy\u002Fimmunomodulatory medications: At least 3 weeks, or 6 weeks if prior nitrosourea.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved the CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Autologous stem cell transplant\u002Finfusion: At least 6 weeks from their infusion after an autologous stem cell infusion following myeloablative therapy. Patients who received an autologous stem cell infusion following non-myeloablative therapy do not have a wash-out period; they are eligible once they meet all other eligibility requirements, including recovery from acute side effects.\n  * Investigational agent: at least 28 days since receiving an investigational agent.\n* Adult participant or the legally authorized representative (LAR) of a minor (defined as \\\u003C18 years of age) must be capable of providing informed consent. When appropriate, pediatric participants ≥7 years of age will participate in an age-appropriate discussion and provide assent, unless an IRB-approved waiver of assent applies and documentation of the participant's eligibility for the waiver is maintained.\n\nRecipient Inclusion Criteria for CAR-TA T cell product Infusion:\n\n* No systemic steroid exposure within 1 week prior to protocol therapy initiation\n* Karnofsky\u002FLansky score of ≥ 60\n* ANC \\> 750\u002FuL\n* Platelet count \\> 75,000\u002FuL\n* Bilirubin ≤ 2.5 mg\u002FdL\n* AST\u002FALT ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs through 6 months following the administration of the CAR-TA T cells\n* Adequate respiratory function defined as oxygen saturation 90% or higher on room air\n* For participants who underwent prior mediastinum-directed therapies (e.g., post radiation to chest): resolution of any respiratory symptoms\n* Adequate respiratory rate, defined as \\\u003C30 breaths per minute for patients aged \\\u003C18 years, and \\\u003C25 breaths per minute for patients aged ≥18 years (respiratory rate may be repeated if initial value is thought to be temporarily abnormal; if repeated, 2 consecutive readings obtained ≥30 minutes apart must be adequate to be eligible)\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* Adequate cardiac function defined as:\n\n  * Shortening fraction of ≥ 27% by echocardiogram, or\n  * Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram\n* The following time frames must have elapsed between completion of prior therapy and the initiation of SABRE protocol therapy:\n\n  * Myelosuppressive chemotherapy: At least 2 weeks from last dose of chemotherapy.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Investigational agent: At least 28 days since receiving an investigational agent.\n* Adult participant or the legally authorized representative (LAR) of a minor (defined as \\\u003C18 years of age) must be capable of providing informed consent. When appropriate, pediatric participants ≥7 years of age will participate in an age-appropriate discussion and provide assent, unless an IRB-approved waiver of assent applies and documentation of the participant's eligibility for the waiver is maintained.\n\nExclusion Criteria:\n\nRecipient Procurement Exclusion Criteria:\n\n* Patients with known CNS disease.\n* Patients with uncontrolled infection\u002Fs or known HIV infection\n* Pregnant or lactating females.\n* Patients who have undergone previous allogeneic stem cell transplant.\n* Inability to tolerate leukapheresis (including any contraindication to the use of Anticoagulant Citrate Dextrose solution).\n\nRecipient Exclusion Criteria for CAR-TA T cell product Infusions:\n\n* Patients with uncontrolled infections or known HIV infection.\n* Pregnant or lactating females\n* Whole lung\u002Fmediastinal radiation within 12 weeks\n* Clinically significant systemic illness or medical condition likely to interfere with assessment of safety or efficacy\n* Patients who have received any live vaccine in the six weeks prior to planned initiation of lymphodepletion\n* Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine, as per the clinical judgment of the PI or treating Sub-I\n* History of allergy or hypersensitivity to study product excipients (e.g., DMSO)","ALL","1 Year","23 Years",{"count":88,"type":89},18,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor.\n\nPatients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight and combined in a 1:1 ratio.\n\nThe safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.",[95,96,97,98],"Rhabdomyosarcoma","Ewing Sarcoma","Neuroblastoma","Wilms Tumor",[100,101],"CAR T Therapy for Embryonal tumors","T cell Therapy for Embryonal tumors","2026-08-11",{"date":104,"type":105},"2026-08-13","ACTUAL",{"date":107,"type":105},"2026-01-27",{"date":109,"type":89},"2044-12",{"name":5,"class":6},2]