[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adrenocortical-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adrenocortical-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100431379","phase-1-b7-h3-specific-chimeric-antigen-receptor-autologous-t-cell-therapy-for-pediatric-patients-with-solid-tumors-3car-100431379",false,"NCT04897321","B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)","Inclusion Criteria:\n\nProcurement and T-cell production eligibility\\*\n\n\\*a previously collected, autologous leukapheresis product can be used for T-cell production\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Rapidly progressive disease (in the opinion of the study PIs)\n\nInclusion criteria\n\nTreatment eligibility\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease\n* Evidence of relapsed or refractory disease after standard first-line therapy\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Echocardiogram with a ventricular ejection fraction\n* \\>40%; or shortening fraction ≥25%\n* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value\n* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Hemoglobin≥ 7g\u002FdL (can be transfused)\n* Platelet count \\>50,000\u002FuL (can be transfused)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products\n\nExclusion criteria\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe, uncontrolled intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion\n* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).\n* Rapidly progressing disease (in the opinion of the study PIs)","ALL","21 Years",{"count":18,"type":19},48,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed\u002Frefractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.\n\nPrimary objective\n\nTo determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent\u002Frefractory B7-H3+ solid tumors after lymphodepleting chemotherapy\n\nSecondary objective\n\nTo evaluate the antitumor activity of B7-H3-CAR T cells\n\nExploratory objectives\n\n* To evaluate the tumor environment after treatment with B7-H3-CAR T cells\n* To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Pediatric Solid Tumor","Osteosarcoma","Rhabdomyosarcoma","Neuroblastoma","Ewing Sarcoma","Wilms Tumor","Adrenocortical Cancer","Desmoplastic Small Round Cell Tumor","Germ Cell Cancer","Rhabdoid Tumor","Clear Cell Sarcoma","Hepatoblastoma","Melanoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","Soft Tissue Sarcoma","RECRUITING","2026-05-18",{"date":44,"type":45},"2026-05-19","ACTUAL",{"date":47,"type":45},"2022-07-06",{"date":49,"type":19},"2028-03-01",{"name":51,"class":52},"St. Jude Children's Research Hospital","OTHER"]