[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-nervous-system-rhabdoid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-nervous-system-rhabdoid-tumor":28},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100632400","phase-1-gpc3-car-t-cells-with-il-15-and-il-21-for-recurrent-atrt-and-cns-rhabdoid-tumors-radiant-100632400",false,"NCT07513194","GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)","Robust Armored Dual-Cytokine (IL-15\u002FIL-21) GPC3-CAR T Cells for Atypical Teratoid Rhabdoid Tumors and Central Nervous System Rhabdoid Tumors (RADIANT)","Procurement Inclusion Criteria:\n\n* 1\\) Diagnosis of GPC3-positive recurrent ATRT.\n* 2\\) Age ≥ 6 months\n* 3\\) Karnofsky\u002FLansky score ≥ 60%\n* 4\\) Informed consent explained to, understood by, and signed by patient\u002Fguardian; copy provided\n* 5\\) GPC3 expression by immunohistochemistry with extent score ≥ Grade 2 (\\>25% positive tumor cells) and intensity score ≥ 2 (scale 0-4)\n\nProcurement Exclusion Criteria:\n\n* 1\\) No history of organ transplantation\n* 2\\) No known HIV positivity\n* 3\\) No active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* 4\\) No other risk factors in which administration of the investigational agent is deemed not in the patient's best interest, in the opinion of the investigator\n\nTreatment Inclusion Criteria:\n\n* 1\\) Age ≥ 6 months\n* 2\\) Diagnosis of treatment refractory or unresectable ATRT after standard of care therapy\n* 3\\) Lansky\u002FKarnofsky score ≥ 60%\n* 4\\) Stable neurologic exam for 7 days prior to enrollment\n* 5\\) Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg\u002Fkg dexamethasone or equivalent per day)\n* 6\\) Not receiving any concurrent anti-cancer therapy.\n* 7\\) At least 6 weeks following craniospinal radiation therapy.\n* 8\\) At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).\n* 9\\) At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy\n* 10\\) Received any other forms of immunotherapy ≤ 42 days before administration of investigational agent\n* 11\\) At least 28 days following bevacizumab\n* 12\\) Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* 13\\) Total bilirubin \\\u003C 3 times ULN for age\n* 14\\) INR ≤ 1.7\n* 15\\) Absolute neutrophil count \\> 500\u002Fμl\n* 16\\) Platelet count \\> 100,000\u002Fμl (can be transfused but must be achieved prior to enrollment)\n* 17\\) Hgb ≥ 7.0 g\u002Fdl (can be transfused)\n* 18\\) Pulse oximetry \\> 90% on room air\n* 19\\) Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* 20\\) Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.\n* 21\\) Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nTreatment Exclusion Criteria:\n\n* 1\\) Pregnancy or lactation (for women at child-bearing age, birth control is required)\n* 2\\) Uncontrolled infection\n* 3\\) Known HIV positivity\n* 4\\) Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* 5\\) History of organ transplantation","ALL","1 Year","21 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity.\n\nThis study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary.\n\nThe purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.",[27,28],"Atypical Teratoid Rhabdoid Tumor","Central Nervous System Rhabdoid Tumor",[30,31,32,27,33,34,35,36,37],"CAR T Cell Therapy","GPC3 CAR T Cells","Glypican-3","CNS Rhabdoid Tumor","Pediatric Brain Tumor","Adoptive Cellular Immunotherapy","Intracerebroventricular Immunotherapy","Solid Tumor CAR T Therapy","NOT_YET_RECRUITING","2026-04-01",{"date":41,"type":42},"2026-04-07","ACTUAL",{"date":44,"type":21},"2026-09-01",{"date":46,"type":21},"2044-10-31",{"name":48,"class":49},"Baylor College of Medicine","OTHER"]