[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rhabdomyosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rhabdomyosarcoma":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,50,77,102,138,211,231,264,289,317,343,373,401,440,466,477,498,526,557,583,607,635,664,693,715],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054031","targeted-oligometastatic-radiation-in-pediatric-and-young-adult-patients-with-soft-tissue-and-bone-sarcoma-100054031",false,"NCT06796543","Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma","TARGET-RT","Stratum A Inclusion Criteria:\n\n* Patients must be aged \\\u003C 39 years at time of enrollment.\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan within 3 weeks from treatment start.\n\nStratum B Inclusion Criteria:\n\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.\n* Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age \\\u003C 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan\n* Radiation to at least one site is being recommended as part of second line therapy.\n\nStratum A Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy\n\nStratum B Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy","ALL","39 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.",[27,28,29,30],"Metastatic Sarcoma","Radiation Therapy Patient","Ewing Sarcoma","Rhabdomyosarcoma",[32,27,33,30,34,35,36],"Pediatric","Ewing sarcoma","Brain tumor","Longitudinal","Radiation Therapy","RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2025-03-25",{"date":45,"type":21},"2030-03",{"name":47,"class":48},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",3,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100632525","integration-of-adaptive-proton-therapy-in-pediatric-solid-tumors-and-hodgkins-lymphoma-100632525","NCT07514819","Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.\n* Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.\n* Research participant or legal guardian\u002Frepresentative gives written informed consent.\n\nExclusion Criteria:\n\n* Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.\n* Participants who are diagnosed with Wilm's tumor or neuroblastoma\n* Participants who do not undergo proton therapy.\n* Participants who are prescribed equal or less than 5 fractions of proton therapy.\n* Participants with severe comorbid conditions that may impact imaging feasibility.\n* Inability to obtain written consent from research participant or legal guardian\u002Frepresentative.\n* Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \\>10 years of age or post-menarchal must have a negative serum or urine pregnancy test\n\nAll participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.",{"count":57,"type":21},100,[24],"Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.\n\nPrimary Objective:\n\n* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.\n* Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.\n\nSecondary Objectives\n\n* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.\n* Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.",[61,30,29,62,63,64,65],"Pediatric Solid Tumors","Osteosarcoma","Hodgkin Lymphoma","Bone Tumor","Soft Tissue Sarcoma","NOT_YET_RECRUITING","2026-06-30",{"date":69,"type":41},"2026-07-02",{"date":71,"type":21},"2026-08",{"date":73,"type":21},"2031-08",{"name":75,"class":48},"St. Jude Children's Research Hospital",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100557680","phase-1-silmitasertib-cx-4945-in-combination-with-chemotherapy-for-relapsed-refractory-solid-tumors-100557680","NCT06541262","Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","Phase I\u002FII Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors","Inclusion Criteria:\n\n1. Age: Less than 30 years old at initial diagnosis\n2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed\u002Frefractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma\n\n   Phase II:\n   * Relapsed\u002Frefractory Neuroblastoma\n   * Relapsed\u002Frefractory Ewing sarcoma\n3. Tumor assessment:\n\n   Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed\u002FRefractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol) and has now relapsed and is in any number of relapses.\n\n   Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.\n\n   International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:\n   1. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification\n   2. Age ≥ 547 days and INRG Stage M regardless of biologic features\n   3. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy\n   4. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy\n\n   Relapsed\u002Frefractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n5. Measurable or evaluable disease, including at least one of the following:\n\n   * Measurable tumor by CT or MRI\n   * MIBG or PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n6. Timing from prior therapy:\n\n   Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.\n   2. Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).\n   4. Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n   5. Stem Cell Transplant:\n\n      * Allogeneic: No evidence of active graft vs. host disease\n      * Allogeneic\u002FAutologous: ≥ 2 months must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n7. Subjects must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 50.\n8. Subjects must have adequate organ function at the time of enrollment:\n\n   * Cardiac: Subjects must have a QTcF ≤ 480 msc.\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C5x upper limit of normal\n   * Renal: Subjects must have adequate renal function defined as:\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \\\u003C 17 years old) (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).\n\nExclusion Criteria:\n\n1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n2. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.\n3. Subjects who are currently receiving Vitamin K antagonists (warfarin).\n4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).\n5. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n8. Subjects with any of the following gastrointestinal disorders:\n\n   1. Active malabsorption (e.g. short gut) syndrome.\n   2. Uncontrolled diarrhea (excess of 4 stools\u002Fday)\n   3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis\n   4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection\n9. Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)\n10. Subjects with a history of any other malignancy.","30 Years",{"count":86,"type":21},104,[88,89],"PHASE1","PHASE2","The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of silmitasertib in combination with chemotherapy\n* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[92,29,62,30,93],"Neuroblastoma","Liposarcoma",{"date":69,"type":41},{"date":96,"type":41},"2024-10-30",{"date":98,"type":21},"2035-11-01",{"name":100,"class":48},"Milton S. Hershey Medical Center",22,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":126,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":76},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","25 Years",{"count":112,"type":21},27,[88,89],"Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[92,30,116,117,118,119,120,121,122,123,124,62,29,125],"Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Wilms Tumor",[127,128,129],"pediatric solid tumors","stem cell transplantation","graft manipulation","2026-06-25",{"date":67,"type":41},{"date":133,"type":41},"2026-02-11",{"date":135,"type":21},"2030-02",{"name":137,"class":48},"University of Florida",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":193,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":76},"100289631","familial-investigations-of-childhood-cancer-predisposition-100289631","NCT03050268","Familial Investigations of Childhood Cancer Predisposition","SJFAMILY","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.\n\nDEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:\n\nIn this protocol, the definition of \"Familial Cancer\" is met if any of the following is present:\n\n* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR\n* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR\n* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR\n* An individual with a congenital cancer diagnosed before 6 months of age; OR\n* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age\n\nº Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.\n\nINCLUSION CRITERIA:\n\n* An individual who meets this protocol's definition of \"Familial Cancer,\" as above.\n* Biologic relatives of an individual meeting this protocol's definition of \"Familial Cancer,\" who are either affected or unaffected by cancer.\n\nEXCLUSION CRITERIA:\n\n* An inability or unwillingness of the research participant or his\u002Fher legally authorized representative (LAR) to provide written informed consent.\n* The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.",{"count":146,"type":21},1500,"OBSERVATIONAL","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.\n\nWhile it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.\n\nThe purpose of this protocol is to identify novel cancer predisposing genes and\u002For genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.\n\nPRIMARY OBJECTIVE:\n\n* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.\n\nSECONDARY OBJECTIVE:\n\n* Identify novel cancer predisposing genes and\u002For genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.",[150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,63,171,172,173,174,175,176,177,92,178,179,180,181,182,183,184,185,186,187,188,189,30,190,191,192],"Acute Leukemia","Adenomatous Polyposis","Adrenocortical Carcinoma","AML","BAP1 Tumor Predisposition Syndrome","Carney Complex","Choroid Plexus Carcinoma","Constitutional Mismatch Repair Deficiency Syndrome","Diamond-Blackfan Anemia","DICER1 Syndrome","Dyskeratosis Congenita","Emberger Syndrome","Familial Acute Myeloid Leukemia","Familial Adenomatous Polyposis","Fanconi Anemia","Familial Cancer","Familial Wilms Tumor","Familial Neuroblastoma","GIST","Hereditary Breast and Ovarian Cancer","Hereditary Paraganglioma-Pheochromocytoma Syndrome","Juvenile Polyposis","Li-Fraumeni Syndrome","Lynch Syndrome","MDS","Melanoma Syndrome","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Neurofibromatosis Type 1","Neurofibromatosis Type II","Nevoid Basal Cell Carcinoma Syndrome","Non Hodgkin Lymphoma","Noonan Syndrome and Other Rasopathy","Overgrowth Syndromes","Pancreatic Cancer","Peutz-Jeghers Syndrome","Pheochromocytoma\u002FParaganglioma","PTEN Hamartoma Tumor Syndrome","Retinoblastoma","Rhabdoid Tumor Predisposition Syndrome","Rothmund-Thomson Syndrome","Tuberous Sclerosis","Von Hippel-Lindau Disease",[194,195,196,197,198,199,200,201,202],"Familial cancer","Genetic predisposition","Heritable disease","Cancer risk","Genome analysis","Genetic modifiers","Next generation sequencing (NGS)","Genetic counseling","DNA","2026-06-15",{"date":205,"type":41},"2026-06-17",{"date":207,"type":41},"2017-04-06",{"date":209,"type":21},"2037-03-31",{"name":75,"class":48},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":49},"100517907","phase-2-treatment-of-newly-diagnosed-rhabdomyosarcoma-using-molecular-risk-stratification-and-liposomal-irinotecan-based-therapy-in-children-with-intermediate-and-high-risk-disease-100517907","NCT06023641","Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease","A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease","Inclusion Criteria:\n\n• Newly diagnosed participants with the diagnosis of rhabdomyosarcoma (RMS) of any subtype. This includes embryonal rhabdomyosarcoma (fusion negative), alveolar rhabdomyosarcoma (fusion positive), as well as spindle cell and sclerosing\n\n• Must have either low-, intermediate-risk or high-risk disease, defined as:\n\n1. Low-risk: TP53 and MYOD1 negative AND\n\n   • Embryonal, congenital\u002Finfantile spindle cell, or spindle cell\u002Fsclerosing FOXO1 fusion negative histology\n   * Stage 1 Group I, Group II\n   * Stage 1 Group III orbital only\n   * Stage 2 Group I, Group II\n2. Intermediate-risk: MYOD1 and TP53 negative AND\n\n   • Embryonal, congenital\u002Finfantile spindle cell, or spindle cell\u002Fsclerosing FOXO1 fusion negative histology o Stage 1 Group III non orbit o Stage 3 Group I\u002FII\n\n   o Stage 2\u002F3 Group III\n   * Stage 4 Group IV and Oberlin 0-1\n\n     • Alveolar, spindle cell\u002Fsclerosing FOXO1 fusion positive histology\n   * Stage 1-3, Group I-III N0\n3. High-risk: All MYOD1 and TP53 mutant tumors regardless of stage and Group AND\u002FOR\n\n   * Embryonal, congenital\u002Finfantile spindle cell or spindle cell\u002Fsclerosing FOXO1 fusion negative o Group IV ≥ 10 year of age and Oberlin ≥ 2\n   * Alveolar, spindle cell\u002Fsclerosing FOXO1 fusion positive\n\n     * N1\n     * Stage 4 Group IV\n\n   See Appendices I and II for Staging and Clinical Grouping.\n\n   Age \\\u003C 22 years (eligible for enrollment until 22nd birthday)\n\n   • Performance level corresponding to ECOG score of 0, 1, or 2. The Lansky performance score should be used for participants \\\u003C 16 years (see Appendix VII).\n   * Participant has received no prior radiotherapy or chemotherapy for rhabdomyosarcoma (excluding steroids) unless an emergency situation requires local tumor treatment (discuss with PI).\n   * Initiation of chemotherapy is planned within 6 weeks (42 days) of the definitive biopsy or surgical resection.\n   * Adequate bone marrow function defined as:\n   * Peripheral absolute neutrophil count (ANC) ≥ 750\u002FμL\n   * Platelet count ≥ 75,000\u002FμL (transfusion independent)\n   * Adequate liver function defined as total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age. Participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met.\n\n   Adequate renal function defined as:\n\n   Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.732 or serum creatinine based on age as follows:\n\n   Age Maximum serum creatinine (mg\u002FdL) Male Female\n\n   1 month to \\\u003C 6 months 0.4 0.4 6 months to \\\u003C 1 year 0.5 0.5 Age Maximum serum creatinine (mg\u002FdL)\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 1.4 \\> 16 years 1.7 1.4\n\n   The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR25 utilizing child length and stature. Data published by the CDC.\n\n   Participants with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract.\n\n   • Adequate pulmonary function defined as: no evidence of dyspnea at rest and a pulse oximetry \\> 94% if there is a clinical indication for determination. Pulmonary function tests are not required.\n\n   • Patients requiring emergency radiation therapy are eligible for enrollment on this trial. See Section 4.11 for radiation therapy guidelines.\n\n   • No evidence of active, uncontrolled infection.\n\n   All participants and\u002For their parents or legal guardians must sign a written informed consent.\n\n   Exclusion Criteria:\n\n   • Patients who have received any chemotherapy (excluding steroids).\n\n   • Patients who have received prior full course RT at the primary site of disease. This does not exclude patients that received emergent radiation.\n   * Ongoing or history of non-infectious interstitial lung disease requiring significant medical intervention.\n   * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed.\n   * Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs. Female participants \\> 10 years of age or post-menarchal must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment.\n   * Lactating females who are or plan to breastfeed their infants are not eligible.","22 Years",{"count":220,"type":21},135,[89],"This is a phase II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.\n\nPrimary Objective\n\n* Estimate event-free survival for intermediate-risk participants treated with VAC and vincristine and liposomal irinotecan (VLI) with the addition of maintenance therapy with vinorelbine and cyclophosphamide.\n* Estimate the event-free survival for high-risk patients treated with VAC and vincristine, liposomal irinotecan, and temozolomide with the addition of maintenance therapy with vinorelbine and cyclophosphamide.\n\nSecondary Objectives\n\n* To assess the relation between pharmacogenetic variation in CEP72 genotype and vinca alkaloid (vincristine; vinorelbine) disposition in children with rhabdomyosarcoma.\n* To assess the relation between the pharmacogenetic variation in drug metabolizing enzymes and drug transporters, and the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma.\n* To assess the extent of inter-patient variability in the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma, and explore possible associations between drug disposition and patient specific covariates (e.g., age, sex, race, weight).\n* Estimate the cumulative incidence of local recurrence and overall 3-year event-free survival in patients with low-risk disease, intermediate-risk disease or high-risk disease treated with either no adjuvant radiation or minimal volume radiation and compare these outcomes with the outcomes achieved on RMS13.",[30],"2026-06-11",{"date":203,"type":41},{"date":227,"type":41},"2024-03-13",{"date":229,"type":21},"2037-10",{"name":75,"class":48},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":238,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":76},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.","18 Years",{"count":7,"type":21},[241],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[244,245,246,247,248,62,65,29,30,249,250,251,252,253,254],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":257,"type":41},"2026-06-05",{"date":259,"type":41},"2026-05-01",{"date":261,"type":21},"2028-05-01",{"name":263,"class":48},"University of California, Irvine",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":84,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100423603","phase-1-vitas-atezolizumab-in-combination-with-chemotherapy-for-pediatric-relapsedrefractory-solid-tumors-100423603","NCT04796012","VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed\u002FRefractory Solid Tumors","VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed\u002FRefractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial","Inclusion Criteria:\n\n1. Signed informed consent\n2. Relapsed or refractory solid tumor after at least one prior course of therapy.\n\n   1. Hodgkin lymphoma or non-Hodgkin lymphoma are not permitted.\n   2. Patients with CNS malignancy or asymptomatic CNS metastases may be enrolled, provided all of the following criteria are met.\n\n      * No metastatic or primary disease affecting the brainstem, midbrain, pons, or cerebellum, or within 10 mm of optic nerve\n      * No history of leptomeningeal disease\n      * No history of intracranial or spinal cord hemorrhage\n      * No evidence of progression of neurologic deficit, in the investigator's judgment, within 7 days prior to initiation of study medications.\n   3. Must have histologically confirmed rhabdomyosarcoma (RMS) for RMS efficacy cohort.\n3. Age ≥ 6 months and ≤ 30 years\n4. Lansky Performance Status (patients \\\u003C 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50\n5. Ability to comply with the study protocol, in the investigator's judgment\n6. For RMS efficacy cohort, disease must be measurable as defined by RECIST v1.1.\n\n   1. For the feasibility cohort, disease must be evaluable, but patients enrolled in the feasibility cohort will be prospectively assessed for measurable disease, RMS patients will also be included in the RMS efficacy cohort.\n   2. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.\n7. Availability of a tumor specimen suitable for determination of PD-L1 status, either from initial diagnosis or from a recurrence.\n\n   1. For PD-L1 staining to be performed at the central site, a formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections must be available along with an associated pathology report prior to study enrollment.\n   2. Patients for whom the required number of slides are not available may still be eligible to enroll on study with PI approval\n8. For the RMS efficacy cohort, it will be required that at least 8 of 17 patients have PD-L1(+) tumor. PD-L1 status will be determined at time of enrollment for all patients. When the maximum allowable number of PD-L1(-) patients has been enrolled and treated on study, PD-L1 positivity will be required for all further enrolled patients.\n\n   1. Staining will be performed in the central site CAP\u002FCLIA-certified laboratory using the 22c3 antibody for immunohistochemical analysis\n   2. PD-L1(+) status will be defined as staining on ≥1% of tumor cells or ≥1% of stroma.\n   3. For the feasibility cohort, PD-L1 positivity is not required but will be performed centrally in all cases for exploratory biomarker studies.\n9. Adequate organ and marrow function as defined by the following laboratory values obtained within 21 days prior to initiation of study medication.\n\n   1. For patients without known bone marrow involvement:\n\n      * Absolute neutrophil count ≥ 1.0 x 10\\^9 \u002F L (1000\u002FµL) without granulocyte colony-stimulating factor support (≥14 days after the last dose of a long-acting growth factor such as pegfilgrastim, or 7 days after short-acting growth factor)\n      * Platelet count ≥ 75 x 10\\^9 \u002F L (75,000\u002FµL) without transfusion in the last 7 days\n   2. Patients with known bone marrow metastatic disease will be eligible for the study if they meet the following criteria:\n\n      * Patients with documented liver metastases: AST and ALT ≤ 5 x ULN\n      * Patients with documented liver or bone metastases: ALP ≤ 5 x ULN\n      * Absolute neutrophil count (ANC) ≥ 750\u002Fmm\\^3\n      * Platelet count ≥ 50,000\u002Fmm\\^3 (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions)\n      * These patients will not be evaluable for hematologic toxicity. At least 4 of 6 patients in the feasibility cohort must be evaluable for hematologic toxicity. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity.\n   3. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age (Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN)\n   4. AST (SGOT) and ALT (SPGT) ≤ 2.5 x ULN for age\n   5. Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n   6. Creatinine ≤ 1.5 x ULN for age or creatinine clearance (or radioisotope glomerular filtration rate) ≥ 70 mL\u002Fmin\u002F1.73 m2\n   7. Left ventricular ejection fraction ≥ 50% or shortening fraction ≥ 30%\n   8. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL)\n   9. Patients may be transfused to meet this criterion.\n   10. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN\n   11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n10. Negative HIV and hepatitis B surface antigen (HBsAg) tests at screening\n11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n    1. Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final doses of atezolizumab, vincristine, and temozolomide. Women must refrain from donating eggs during this same period.\n    2. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus), regardless of sexual orientation or marital status.\n    3. Examples of contraceptive methods with a failure rate of \\< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n    4. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n12. For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n    1. With a female partner of childbearing potential who is not pregnant, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less 1% per year during the treatment period and for 5 months after the final doses of atezolizumab, irinotecan, and temozolomide. Men must refrain from donating sperm during this same period.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding:\n\n   1. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment\n   2. Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study treatment.\n2. Medical conditions that are excluded:\n\n   1. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Guillain-Barré syndrome, multiple sclerosis, or Kawasaki syndrome with the following exceptions:\n\n      * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n      * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n      * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met at study initiation: (1) Rash must cover less 10% of body surface area, (2) Disease is well controlled at baseline and requires only low-potency topical corticosteroids, (3) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n   2. Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n   3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n      * Patients with indwelling catheters (e.g., PleurX®) are allowed.\n   4. Uncontrolled tumor-related pain\n\n      * Patients requiring pain medication must be on a stable regimen at study entry for at least 2 weeks. Intermittent use of as-needed medication is allowed during this period.\n   5. Clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (at the discretion of the treating physician)\n   6. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n      * History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n   7. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n   8. History of severe asthma or uncontrolled asthma\n   9. Dyspnea at rest or requirement for supplemental oxygen\n   10. Uncontrolled seizures. Patients taking a stable dose of anticonvulsants (for 2 weeks) are permitted, as long as they are not strong inducers or inhibitors of CYP3A4.\n   11. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator\n3. Washout periods from prior therapies:\n\n   1. Myelosuppressive chemotherapy or radiotherapy within 21 days prior to starting study treatment.\n\n      * Subjects must have recovered from all acute prior treatment-related toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism).\n   2. Non-myelosuppressive cancer therapy, such as kinase inhibitors, within 7 days prior to study treatment.\n   3. Treatment with monoclonal antibodies with long half-lives, within 3 half-lives prior to study treatment.\n   4. Treatment with targeted cellular therapies within 28 days prior to starting study treatment.\n   5. Major surgical procedure, other than for diagnosis, within 30 days prior to initiation of study treatment, or anticipation of the need for a major surgical procedure during the first four cycles of the study.\n\n      * Biopsy tissue collection or placement of a vascular access device is permitted if the site has healed prior to initiation of study medications.\n      * For patients with CNS disease, no neurosurgical resection, brain biopsy, or stereotactic\u002Fwhole-brain radiation within 30 days prior to Cycle 1, Day 1\n   6. Treatment with a live, attenuated vaccine within 30 days prior to initiation of study treatment, or anticipation of the need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n   7. Treatment with investigational therapy within 21 days prior to initiation of study treatment or concurrent participation with another investigational agent\n   8. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n   9. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-agents) within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n      * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n      * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n      * Patients with CNS disease can be receiving concurrent treatment with corticosteroids with approval from the Principal Investigator. Patients must be receiving a stable or decreasing dose for ≥ 5 days prior to the baseline MRI scan and at the time of drug initiation. The Principal Investigator should be informed when steroid doses are increased because of declining patient status.\n   10. Use of strong CYP3A4 inhibitors or inducers or strong UGT1A1 inhibitors within 12 days of Cycle 1, Day 1.\n   11. Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within 3 months prior to initiation of study drug\n   12. Treatment with herbal cancer therapy within 1 week prior to initiation of study medications.\n   13. Treatment with a long-acting hematopoietic growth factor (such as pegfilgrastim) within 2 weeks prior to initiation of study medications, or a short-acting hematopoietic growth factor (such as G-CSF) within 1 week prior to initiation of study medications.\n4. Prior treatments:\n\n   1. Prior allogeneic stem cell or solid organ transplantation\n   2. Prior treatment with CD137 agonists or immune checkpoint blockade therapies to include all anti-PD-1, and anti-PD-L1 therapeutic antibodies\n   3. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n   4. Subjects must not have previously progressed while receiving regimens that include irinotecan or temozolomide. Patients who have received irinotecan or temozolomide and did not progress while on these medications are eligible.\n5. Known ongoing or untreated infection, including, but not limited to bacteremia, active tuberculosis, or severe pneumonia\n\n   1. Active tuberculosis\n   2. Current treatment with anti-viral therapy for HBV\n   3. Active hepatitis C\n   4. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study\n6. Known allergy or hypersensitivity to any component of the study medications\n\n   1. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n   2. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation",{"count":272,"type":21},23,[88,89],"This trial is a multi-center, non-randomized, open-label Phase I\u002FII study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed\u002Frefractory solid tumors.",[276,30],"Solid Tumor",[278,279,30],"Relapsed solid tumor","Refractory solid tumor","2026-05-29",{"date":255,"type":41},{"date":283,"type":41},"2023-04-18",{"date":285,"type":21},"2027-01",{"name":287,"class":48},"University of Texas Southwestern Medical Center",7,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100606238","phase-1-selective-antigen-specific-t-cells-and-car-t-cells-in-subjects-with-relapsedrefractory-embryonal-tumors-sabre-100606238","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: o Shortening fraction of ≥ 27% by echocardiogram, or o 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* Patient or parent\u002Fguardian capable of providing informed consent.\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 (See Appendix 3)\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 (as described in Appendix 5) 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* 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* Patient or parent\u002Fguardian capable of providing informed consent.\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\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","1 Year","23 Years",{"count":300,"type":21},18,[88],"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.\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.",[30,29,92,125],[305,306],"CAR T Therapy for Embryonal tumors","T cell Therapy for Embryonal tumors","2026-05-20",{"date":309,"type":41},"2026-05-22",{"date":311,"type":41},"2026-01-27",{"date":313,"type":21},"2038-12",{"name":315,"class":48},"Children's National Research Institute",2,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":76},"100431379","phase-1-b7-h3-specific-chimeric-antigen-receptor-autologous-t-cell-therapy-for-pediatric-patients-with-solid-tumors-3car-100431379","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)","21 Years",{"count":325,"type":21},48,[88],"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",[329,62,30,92,29,125,330,120,331,122,118,332,250,333,334,65],"Pediatric Solid Tumor","Adrenocortical Cancer","Germ Cell Cancer","Hepatoblastoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","2026-05-18",{"date":337,"type":41},"2026-05-19",{"date":339,"type":41},"2022-07-06",{"date":341,"type":21},"2028-03-01",{"name":75,"class":48},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":351,"maxAge":238,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":76},"100641039","phase-1-phase-i-study-of-becotatug-vedotin-for-safety-and-efficacy-in-egfr-positive-pediatric-relapsedrefractory-or-metastatic-solid-tumors-100641039","NCT07584499","Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed\u002FRefractory or Metastatic Solid Tumors","A Phase I Clinical Study to Explore the Safety and Efficacy of Becotatug Vedotin in Pediatric Patients With EGFR-Positive Relapsed\u002FRefractory or Metastatic Solid Tumors","MRG003","Inclusion Criteria:\n\n* All participants must meet all of the following criteria to be eligible for enrollment:\n\nInformed Consent: The patient (and\u002For legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs a written informed consent form (ICF). A separate biomarker consent form is required for EGFR testing prior to screening.\n\nAge: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.\n\nHistologically Confirmed Disease: Pathologically confirmed relapsed\u002Frefractory or metastatic EGFR-positive solid tumor, belonging to one of the following subtypes:\n\nHead and neck squamous cell carcinoma, nasopharyngeal carcinoma, or lymphoepithelial carcinoma that progressed during or after at least one line of platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitor therapy Rhabdomyosarcoma Neuroblastoma Medulloblastoma Wilms tumor Atypical teratoid\u002Frhabdoid tumors (AT\u002FRTs) Diffuse intrinsic pontine gliomas (DIPGs) Other EGFR-positive solid tumor subtypes deemed eligible by the investigator Measurable Disease: At least one measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria (longest diameter ≥10 mm; pathological lymph node short axis ≥15 mm).\n\nPerformance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n\nAdequate Bone Marrow Function:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥75 × 10⁹\u002FL Hemoglobin ≥80 g\u002FL Exception for patients with bone marrow involvement: ANC ≥1.0 × 10⁹\u002FL, platelets ≥50 × 10⁹\u002FL, hemoglobin ≥75 g\u002FL\n\nAdequate Hepatic and Renal Function:\n\nSerum creatinine ≤1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Exception for patients with liver involvement: AST\u002FALT ≤5 × ULN, total bilirubin ≤3 × ULN\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they meet any of the following criteria:\n\nHypersensitivity: Known hypersensitivity to any component of Becotatug Vedotin (MRG003) or its excipients.\n\nSymptomatic CNS Metastases: Presence of symptomatic central nervous system (CNS) metastases.\n\nPrior Malignancies: History of other primary malignant tumors, except for:\n\nLocally excised basal cell or squamous cell carcinoma of the skin Cervical carcinoma in situ Any prior malignancy that has been in complete remission for ≥3 years without treatment Note: Melanoma (any stage) is explicitly excluded\n\nSignificant Liver Disease: Clinically significant liver disease, including:\n\nPositive hepatitis C virus (HCV) antibody Chronic active hepatitis B (HBV DNA \\>20,000 IU\u002FmL) HIV Infection: Known human immunodeficiency virus (HIV) infection. Severe Ocular Abnormalities: History of severe ophthalmologic conditions, such as severe dry eye syndrome or exposure keratitis.\n\nUncontrolled Systemic Diseases: Severe or uncontrolled medical conditions, including:\n\nInterstitial lung disease or pneumonitis Active autoimmune diseases requiring systemic immunosuppressive therapy\n\nCardiac Disease: Clinically significant cardiac dysfunction or cardiac disease, including:\n\nCongestive heart failure (New York Heart Association Class ≥II) Uncontrolled arrhythmias QTc interval prolongation \\>450 ms (males) or \\>470 ms (females) Recent Antitumor Therapy: Received any systemic antitumor therapy (chemotherapy, biological therapy, immunotherapy, targeted therapy) within 3 weeks prior to the first dose of study drug, and have not recovered to CTCAE v4.03 Grade ≤1 (except alopecia).\n\nRecent Major Surgery: Underwent major surgical procedure within 3 weeks prior to the first dose of study drug.\n\nPlanned Surgery: Planned surgical procedure during the study period, or any surgery deemed necessary by the investigator.\n\nPrior EGFR Therapy Toxicity: History of severe skin toxicity caused by prior EGFR-targeted therapy, or chronic skin disease requiring ongoing oral or intravenous treatment.\n\nOther Significant Risks: Any other concurrent medical condition that, in the investigator's judgment, would increase the risk of toxicity or compromise the patient's ability to complete the study.","2 Years",{"count":353,"type":21},51,[88],"There is a significant unmet medical need for effective therapies for pediatric relapsed\u002Frefractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug Vedotin demonstrated a manageable safety profile and promising antitumor activity in EGFR-positive advanced solid tumors.This is a multicenter, non-randomized, single-arm, open-label Phase I clinical trial sponsored by Sun Yat-sen University Cancer Center (SYSUCC). The trial evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of Becotatug Vedotin-an EGFR-targeted antibody-drug conjugate (ADC)-in pediatric patients with EGFR-positive relapsed\u002Frefractory or metastatic solid tumors.",[357,358,359,30,92,360,125,361,362,363],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Nasopharyngeal Carcinoma","Lymphoepithelial Carcinoma","Medulloblastoma","Atypical Teratoid\u002FRhabdoid Tumors","Diffuse Intrinsic Pontine Gliomas","Other EGFR-positive Pediatric Solid Tumors Deemed Eligible by the Investigator","2026-05-07",{"date":366,"type":41},"2026-05-13",{"date":368,"type":21},"2026-05-30",{"date":370,"type":21},"2028-05-30",{"name":372,"class":48},"Sun Yat-sen University",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":351,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":400},"100523316","phase-1-personalized-vaccination-in-fusion-sarcoma-patients-pervision-100523316","NCT06094101","Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)","Prospective Phase I\u002FII Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment","PerVision","Inclusion Criteria, definition of partial remission plus (PRplus)\n\n* Screening Stage 1:\n\n  * Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.\n  * Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER (Register study Molecularly Aided Stratification for Tumor Eradication) or HEROES-AYA networks (Heterogeneity, evolution and resistance of fusion-driven sarcomas in AYA) or similar evaluation.\n* Screening stage 2:\n\n  * Design and production of the patient-individual vaccine cocktail was successful\n  * Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and\u002For maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed. Definition of PRplus: Partial remission(plus) implicates that all remaining tumor residua including all metastases have received local therapy by this time point: Either surgical removal or local irradiation. The assessment of which therapy modality and, in the case of irradiation, which radiation dose is selected, lies with the treating physician. Whether PRplus is achieved will be decided finally by the investigator after review of the patient records.\n\nExclusion Criteria:\n\n* Ejection fraction \\\u003C 25%\n* Creatinine-clearance \\\u003C 40ml\u002Fmin\n* Bilirubin \\> 4mg\u002Fdl\n* Alanine aminotransferase (ALT) \\> 400 units (U)\u002Fl and\u002For aspartate aminotransferase (AST) \\> 400 U\u002Fl\n* Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen\u002Fantibody or nucleic acid tests \\[NAT\\]) and CD4-positive cells \\\u003C 500\u002Fμl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\]) and hepatitis B NAT test \\> 2000 IU\u002Fml). Hepatitis C virus: positive for heavy chain only antibody \\[HCAb\\] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)\n* Subjects with a known hypersensitivity \u002F allergy to any component of the study drugs.\n* Subjects who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).\n* Subjects with a prior haematopoietic stem cell transplantation \u002F prior organ transplantation.\n* Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.\n* Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence functionality and activity of T cells, such as steroids (more than 0,5 mg\u002Fkg body weight prednisolone-equivalent), calcineurin-inhibitors, mofetil mycophenolate, sirolimus, everolimus, and cytotoxic medication. Those drugs should be avoided until 28 days after third\u002Ffinal vaccination but may be given after discussion with the principal investigator. Application of tyrosine kinase inhibitors is permitted during the trial (only stage 2).\n* Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.\n* Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy\u002Fleucoencephalopathy (\\> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).\n* Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment\n* Pregnant females\n* Female subjects of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior to Screening stage 2 visit to 180 days after the last vaccination.\n* Male subjects of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.\n* Not willing and\u002For not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.\n* History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may include but is not limited to: history of central nervous system or cardiovascular disease, history of relevant drug allergies, history of psychiatric disorder, history or present of clinically significant pathology.\n* Karnofsky performance status of \\\u003C 70% for subjects ≥ 16 years of age, Lansky performance status of \\\u003C 70% for subjects \\\u003C 16 years of age\n* Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the \"frontline and relapsed rhabdomyosarcoma study\"( (FaR-RMS) after completion of the maintenance therapy (EudraCT-2018-000515-24)). Commonly used drugs as per standard or phase III-trials are permitted.","40 Years",{"count":383,"type":21},30,[88,89],"The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.\n\nThis approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.\n\nIt is an interventional, multicenter, open-label, phase I\u002FII feasibility and early proof of concept study evaluating a personalized peptide vaccine.\n\nPrimary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.",[29,30,116],[388,389,390],"metastasized fusion-driven sarcoma","clinical study","phase I\u002FII","2026-04-28",{"date":393,"type":41},"2026-05-04",{"date":395,"type":41},"2023-09-19",{"date":397,"type":21},"2027-09",{"name":399,"class":48},"University Hospital Tuebingen",4,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":409,"maxAge":238,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":419,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":439},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997","NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","24 Months",{"count":411,"type":21},20,[88],"The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[415,416,252,276,417,30,418,168],"Somatostatin Receptor Positive","NETs","CNS Tumors","Peripheral Primitive Neuroectodermal Tumor",[32,420,421,252,422,423,424,425,426,427,428,429],"CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood","2026-04-27",{"date":259,"type":41},{"date":433,"type":41},"2025-09-26",{"date":435,"type":21},"2034-04",{"name":437,"class":438},"ITM Solucin GmbH","INDUSTRY",5,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":448,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":76},"100597165","tumor-lymph-node-mapping-100597165","NCT07054944","Tumor-Lymph Node Mapping","FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)","T-LyM","Inclusion Criteria:\n\n* Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery.\n* Diagnosed with pediatric solid tumor\n* Scheduled to undergo lymph node sampling as part of their clinical management.\n\nExclusion Criteria:\n\n* Subjects with a history of iodide allergies.\n* Inability or unwillingness of research participant or parent\u002Flegal guardian to give written informed consent.\n* Currently pregnant.\n* Infants under 650 grams.\n* Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.","1 Month","17 Years",{"count":451,"type":21},10,"The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection\u002Fsampling.\n\nThis trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.",[61,30,454,251],"Sarcoma",[456],"PEDIATRIC CANCER","2026-04-20",{"date":459,"type":41},"2026-04-23",{"date":461,"type":21},"2026-04-13",{"date":463,"type":21},"2028-07-30",{"name":465,"class":48},"University of Rochester",{"id":467,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":25,"conditions":470,"keywords":471,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":476,"locationsCount":316},"100577303",{"count":20,"type":21},[24],[27,28,29,30],[32,27,33,30,34,35,36],"2026-04-17",{"date":457,"type":41},{"date":43,"type":41},{"date":45,"type":21},{"name":47,"class":48},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":84,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":76},"100386177","phase-1-vorinostat-in-combination-with-chemotherapy-in-relapsedrefractory-solid-tumors-and-cns-malignancies-100386177","NCT04308330","Vorinostat in Combination With Chemotherapy in Relapsed\u002FRefractory Solid Tumors and CNS Malignancies","A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies","NYMC195","Inclusion Criteria:\n\n* Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy.\n* Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy.\n* Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50.\n* Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination.\n\n  * Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy.\n  * Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days.\n  * Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy.\n  * Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation.\n  * Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.\n* Organ function:\n\nBone marrow function:\n\n* Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells\u002FmcL.\n* Platelet count greater than or equal to100,000\u002FmcL and no platelet transfusion within prior 7 days.\n* Hemoglobin greater than or equal to 8 gm\u002FdL\n* Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells\u002FmcL. They will not be evaluable for hematologic toxicity.\n\n  \\- Adequate liver function:\n* Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age.\n* SGPT (ALT) less than or equal to 5x ULN\n* Serum albumin greater than or equal to 2 gm\u002FdL\n\n  \\- Adequate renal function:\n* Creatinine clearance or glomerular filtration rate \\>70 ml\u002Fmin\u002F1.73 m2 or a serum creatinine based on age and gender as follows:\n\nAge Maximum serum creatinine concentration (mg\u002FdL) Male Female 1-\\\u003C2 years 0.6 0.6 2-\\\u003C6 years 0.8 0.8 6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13-\\\u003C16 years 1.5 1.4 greater than or equal to 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula to estimate glomerular filtration rates (Schwartz et al. J. Peds. 106; 522. 1985) using child length and stature data from the CDC.\n\n\\- Informed consent: All patients less than 18 years of age must sign a written informed consent. For patients \\\u003C18 years of age, a parent or guardian must sign a written informed consent, unless the patient is an emancipated minor. Childhood assent, when appropriate, should be obtained as well per institutional guidelines.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy.\n* Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy.\n* Antineoplastic therapy: Patients receiving any other antineoplastic therapy.\n* Medication allergy:\n\nAllergy or intolerance to any of the protocol agents: vincristine, irinotecan, temozolomide, or vorinostat.\n\nAllergy or intolerance to cephalosporins.\n\n* Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection.\n* Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.\n* Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.",{"count":383,"type":21},[88],"Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy.\n\nThe goals of this study are:\n\n* To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects;\n* To learn what kind of side effects this four drug combination can cause;\n* To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells;\n* To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.",[29,30,125,92,332,251],"2026-04-10",{"date":491,"type":41},"2026-04-15",{"date":493,"type":41},"2017-03-17",{"date":495,"type":21},"2027-12-31",{"name":497,"class":48},"New York Medical College",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":323,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":76},"100417400","phase-1-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-expressed-in-t-cells-for-pediatric-solid-tumors-100417400","NCT04715191","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE)","Procurement Eligibility\n\nInclusion Criteria:\n\n* Diagnosis of GPC3-positive\\* solid tumors (as determined by immunohistochemistry with an extent score of \\>=Grade 2 \\[\\>25% positive tumor cells\\] and an intensity score of \\>= 2 \\[scale 0-4\\]).\n* Age ≥1 year and ≤ 21 years\n* Lansky or Karnofsky score ≥60%\n* Life expectancy ≥16 weeks\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* Child-Pugh-Turcotte score \\\u003C7 (for patients with hepatocellular carcinoma only)\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).\n* History of organ transplantation\n* Known HIV positivity\n* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n\nTreatment Eligibility\n\nInclusion Criteria:\n\n* Age ≥ 1 year and ≤ 21 years\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* Lansky or Karnofsky score ≥ 60%\n* Child-Pugh-Turcotte score \\\u003C 7 (for patients with hepatocellular carcinoma only)\n* Adequate organ function:\n* Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* Total bilirubin \\\u003C 3 times ULN for age\n* INR ≤1.7 (for patients with hepatocellular carcinoma only)\n* Absolute neutrophil count \\> 750\u002Fµl\n* Platelet count \\> 75,000\u002Fµl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Hgb ≥ 8.0 g\u002Fdl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Pulse oximetry ≥ 92% on room air\n* Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy)\n* Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, as determined by history and physical exam.\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24 hours prior to CAR T cell infusion)\n* Known HIV positivity\n* Active bacterial, fungal or viral infection \\[except Hepatitis B (HBV patients with active disease who meet the criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy) or Hepatitis C virus infections (should have completed curative antiviral treatment with HCV viral load below the limit of quantification\\]\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n* History of organ transplantation\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)",{"count":506,"type":21},24,[88],"Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CARE T cells, a new experimental treatment.\n\nThe body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.\n\nInvestigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries a person's traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added two genes that includes IL15 and IL21, which are protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 plus IL21 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 plus IL21 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nT cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 plus IL21 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects.\n\nThis study will test T cells genetically engineered with a GPC3-CAR and IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nThe CARE T cells are an investigational product not approved by the Food and Drug Administration.\n\nThe purpose of this study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the CARE T cells will help people with GPC3-positive solid tumors.",[510,30,511,93,125,512],"Liver Cancer","Malignant Rhabdoid Tumor","Yolk Sac Tumor",[514,515,516],"15.21.GPC3-CAR T cells","GPC3","Glypican","2026-04-01",{"date":519,"type":41},"2026-04-06",{"date":521,"type":41},"2024-05-24",{"date":523,"type":21},"2041-07-03",{"name":525,"class":48},"Baylor College of Medicine",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":532,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":542,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":76},"100632643","mynavigate-a-guide-to-after-treatment-effects-for-adolescents-and-young-adults-100632643","NCT07516353","my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults","Inclusion Criteria:\n\n* Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.\n* Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.\n* Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia\u002FLymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.\n* Patients whose treatment includes alkylators, anthracyclines, and\u002For radiation.\n\nInclusion of Children:\n\n• This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be \\\u003C18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and\u002For those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.\n\nExclusion Criteria:\n\n* Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.\n* Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.\n* Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.\n* We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.","15 Years","24 Years",{"count":535,"type":21},143,[24],"This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).",[454,62,29,30,539,540,17,360,541],"Acute Myeloid Leukemia","Aml","Acute Lymphoblastic Leukemia ,Lymphomas",[543,544,545,546,547,454,62,29,30,539,540,17,360],"Cancer Survivorship","Adolescent and Young Adult Cancer","Late Effects of Cancer Treatment","Hodgkin and mature B-cell Lymphomas","Acute Lymphoblastic Leukemia\u002FLymphoma","2026-03-31",{"date":550,"type":41},"2026-04-08",{"date":552,"type":21},"2026-08-20",{"date":554,"type":21},"2030-12-31",{"name":556,"class":48},"Dana-Farber Cancer Institute",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":564,"maxAge":18,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":76},"100582619","phase-1-fgfr4-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-rhabdomyosarcoma-100582619","NCT06865664","FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma","Phase I Dose Escalation Study of FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma","* INCLUSION CRITERIA\n* Histologically confirmed rhabdomyosarcoma by the NCI Department of Pathology.\n\nNote: Since FGFR4 expression is universal in rhabdomyosarcoma, confirmation of FGFR4 expression is not required.\n\n* Relapsed or refractory rhabdomyosarcoma after at least two (2) cancer treatment regimens i.e., participants should have relapsed or progressed after upfront therapy (that includes any systemic chemotherapy with or without local control) as well as at least one salvage therapy (which can be systemic therapy, radiation, or surgery).\n* No available alternative curative therapies per standard of care.\n* Participants must have measurable disease per RECIST 1.1 or non-measurable disease on imaging.\n* Age \\>= 3 and \\\u003C= 39 years old.\n* Weight \\>=15 kg.\n* Performance status: Karnofsky \\>= 50% (\\>= 16 years) or Lansky \\>= 50% (\\\u003C 16 years).\n\nNote: Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for calculating the performance score.\n\n* Participants must be willing to accept blood transfusions.\n* Adequate organ and marrow function as defined below:\n\n  * Organ: Bone Marrow Function\\*\n\n    * Laboratory Element: Absolute neutrophil count; Minimum Requirement \\>= 500\u002FmcL\n    * Laboratory Element: Platelets; Minimum Requirement \\>= 50,000\u002FmcL\n\n      \\*Transfusion independent (defined as no transfusion in the prior 7 days) for participants without bone marrow involvement. Participants who have bone marrow involvement with tumor are exempt from the platelet requirement and will not be evaluable for hematological toxicities. Participants must not be refractory to transfusions.\n  * Organ: Liver Function\n\n    * Laboratory Element: Aspartate aminotransferase (AST); Minimum Requirement \\\u003C= 5 x upper limit of normal (ULN)\n    * Laboratory Element: Alanine aminotransferase (ALT); Minimum Requirement \\\u003C= 5 x ULN\n    * Laboratory Element: Total bilirubin; Minimum Requirement \\\u003C= 2 x ULN (Note: Participants with Gilbert's syndrome and\u002For bilirubin elevation due to tumor involvement are allowed to have \\\u003C= 5 x ULN)\n\nNote: Adult values will be used for calculating hepatic toxicity and determining eligibility\n\n--Organ: Renal Function\n\n* Age: 3 to \\\u003C 6 years; Maximum serum creatinine (mg\u002FdL): Male - 0.8, Female - 0.8\n* Age: 6 to \\\u003C 10 years; Maximum serum creatinine (mg\u002FdL): Male - 1, Female - 1\n* Age: 10 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): Male - 1.2, Female - 1.2\n* Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): Male - 1.5, Female - 1.2\n* Age: \\>= 16 years; Maximum serum creatinine (mg\u002FdL): Male - 1.7, Female - 1.4\n\nOR\n\n* Measured or calculated creatinine clearance or glomerular filtration rate (GFR); Minimum Requirement: \\>= 60mL\u002Fmin\u002F1.73 m\\^2\n\n  --Organ: Cardiac Function\n* Laboratory Element: Cardiac status; Minimum Requirement: Cardiac ejection fraction \\>= 45% or shortening fraction \\>= 28%, pericardial effusion \\\u003C= grade 2 as determined by an echocardiogram (ECHO)\n\n  * Organ: Pulmonary Function\n* Laboratory Element: Pulmonary status; Minimum Requirement: Pleural effusion \\\u003C= grade 1; Oxygen (O2) saturation \\>=92% on room air at rest\n\n  --Organ: Neurological Function\n* Laboratory Element: Neurologic status; Minimum Requirement: No acute neurotoxicity greater than grade 2 per CTCAE v.5.0 with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible.\n\n  * Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy or 6 months after FGFR4-CAR T cells infusion, whichever is later. Individuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 4 months after the last dose of combined chemotherapy or 6 months after FGFR4-CAR T cells infusion, whichever comes later. We also will recommend individuals who can\n\nfather children with IOBCP partners ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals who can father children must not freeze or donate sperm within the same period.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after completion of chemotherapy preparative administration or 6 months after FGFR4-CAR T cells infusion, whichever is later.\n* Participants with previous central nervous system (CNS) tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy as evidenced by no requirements for corticosteroids, no evolving neurologic deficits, and no progression\n\nof residual brain abnormalities without specific therapy, are permitted. Participants with asymptomatic subcentemeric CNS lesions are permitted if no immediate radiation or surgery is indicated.\n\n* Participants must be willing to be enrolled into protocol 15C0028 \"Follow-Up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials\" after 5 years on this trial.\n* The ability of participant or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n* Prior therapy with the following prior to apheresis:\n\n  * tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen within \\\u003C= 1 week\n  * systemic chemotherapy within \\\u003C= 2 weeks\n  * antineoplastic antibody therapy, checkpoint inhibitors, or vaccine therapy, within \\\u003C= 3 weeks or 5 half-lives (whichever is shorter)\n  * radiation within \\\u003C= 3 weeks (\\\u003C= 6 weeks if CNS or lung fields have been radiated or in case of craniospinal irradiation of radiation of \\>=50% of bony pelvis and \\\u003C=12 weeks in case of total body irradiation). Note: There is no time restriction if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation port\n  * any investigational agents within \\\u003C= 4 weeks\n  * autologous stem cell infusion following myeloablative therapy within \\\u003C= 6 weeks\n  * genetically modified T cell, NK cell, or dendritic cell therapy within \\\u003C= 6 weeks\n  * allogeneic stem cell transplant\u002Finfusion within \\\u003C=12 weeks or evidence of active graft versus host disease (GVHD)\n* Participants receiving more than physiologic dosing of systemic steroids (3 mg\u002Fm\\^2\u002Fday of prednisone equivalent).\n* History of severe, immediate hypersensitivity reaction attributed to any agents used in the study or in the manufacturing of the cells.\n* Second malignancy at any time.\n* Primary immunodeficiency.\n* Seropositive for human immunodeficiency virus (HIV) antibody.\n* Seropositive for hepatitis C (HCV) or positive for Hepatitis B (HBV) surface antigen (HbsAg).\n* Pregnancy confirmed with beta-HCG serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness or social situations that would limit compliance with study requirements.","3 Years",{"count":566,"type":21},50,[88],"Background:\n\nRhabdomyosarcoma (RMS) is a cancer of soft tissues. It is the most common soft tissue sarcoma seen in children. RMS cancer cells have a protein called FGFR4 on their surface. Researchers want to try a new kind of treatment for RMS: They will collect a person s own T cells, a type of immune cell; then they will change the T cells so they are better able to target the FGFR4 protein and attack RMS tumor cells. The modified T cells are chimeric antigen receptor (CAR) T cells. The treatment in this study is called FGFR4-CAR T cells.\n\nObjective:\n\nTo test FGFR4-CAR T cells in children and young adults with RMS.\n\nEligibility:\n\nPeople aged 3 to 39 years with RMS. The RMS must have failed to respond or returned after at least 2 rounds of standard treatment.\n\nDesign:\n\nParticipants will be screened. They will have physical exam, imaging scans, blood tests, and tests of their heart. They may have a tissue sample taken from their tumor.\n\nThey will undergo apheresis: Blood will be taken from the body through a catheter. The blood will pass through a machine that separates out the T cells, and the remaining blood will be returned to the body. The collected T cells will be taken to a lab to create FGFR4-CAR T cells.\n\nOnce the FGFR4-CART cells are ready, participants can receive these T cells. For 4 days they will receive drugs to prepare their body for the FGFR4-CAR T cells. After this, the modified T cells will be infused into a vein.\n\nParticipants will be then monitored closely to watch for any side effects from the CART cells and be followed to see what effect the CART cells have on their tumors. They will have follow-up visits for up to 5 years. Long-term follow-up will be another 10 years.",[30],[454,276,571,30,572],"CAR T Cells","FGFR4","2026-03-13",{"date":575,"type":41},"2026-03-16",{"date":577,"type":41},"2025-09-22",{"date":579,"type":21},"2029-04-01",{"name":581,"class":582},"National Cancer Institute (NCI)","NIH",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":4},"100628797","phase-3-a-study-comparing-higher-dose-chemotherapy-over-a-shorter-amount-of-time-to-lower-dose-chemotherapy-plus-maintenance-over-a-longer-amount-of-time-in-patients-with-newly-diagnosed-intermediate-risk-rhabdomyosarcoma-ir-rms-100628797","NCT07466316","A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)","A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC\u002FVI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma","Inclusion Criteria:\n\n* Patient must be ≤ 50 years of age at the time of enrollment\n* Patients with newly diagnosed soft tissue RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon FOXO1 fusion status, Stage, Intergroup Rhabdomyosarcoma Study (IRS) group, and age, as below. FOXO1 fusion status must be determined prior to enrollment. RMS types included under embryonal rhabdomyosarcoma (ERMS) include those which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (typical, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar Rhabdomyosarcoma (ARMS) in the 2020 WHO Classification is the same as in the International Classification of Rhabdomyosarcoma (ICR) and includes classic and solid variants.\n\n  * FOXO1 fusion negative (FN)\n\n    * Stage 2\u002F3, Group III\n    * Stage 4, Group IV, \\\u003C 10 years old\n  * FOXO1 fusion positive (FP)\n\n    * Stages 1-3, Groups I-III\n  * Disease\u002Fstaging imaging studies, if applicable, must be obtained within 21 days prior to enrollment and start of protocol therapy (repeat if necessary)\n* FOXO1 status results must be available to enroll. All patients will undergo institutional pathology review and institutional FOXO1 fusion determination regardless of histology prior to enrollment. FOXO1 status may confirmed by cytogenetic, fluorescence in situ hybridization (FISH), or next generation sequencing techniques. FOXO1 fusion results should be SUBMITTED as an upload to RAVE at study enrollment because this information is required for randomization.\n\nPlease note the following:\n\n* Institutional PAX3 versus (vs.) PAX7 determination is not required but should be submitted if available. Institutional FOXO1 testing may be performed at a contract or commercial lab as long as reports can be submitted and uploaded to RAVE. Additional molecular pathology reports, including the MCI report, are not required but should be submitted if available.\n* Patients who are \\\u003C 10 years old with distant metastatic disease (Stage 4) who have institutional molecular testing indicating fusion negative (FN) RMS but are later found to have fusion positive (FP) RMS by MCI or other testing will be considered to have metastatic FP disease and will go off study\n\n  * Appropriate lymph node sampling based on primary site of disease is required\n  * Patients must have a performance status of Lansky performance status score ≥ 50 for patients ≤ 16 years of age or Karnofsky performance status score ≥ 50 for patients \\> 16 years of age\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * Platelet count ≥ 75,000\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * For pediatric patients \\\u003C 18 years of age:\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Maximum serum creatinine 0.4 mg\u002FdL (male), 0.4 mg\u002FdL (female)\n  * 6 months to \\\u003C 1 year: Maximum serum creatinine 0.5 mg\u002FdL (male), 0.5 mg\u002FdL (female)\n  * 1 to \\\u003C 2 years: Maximum serum creatinine 0.6 mg\u002FdL (male), 0.6 mg\u002FdL (female)\n  * 2 to \\\u003C 6 years: Maximum serum creatinine 0.8 mg\u002FdL (male), 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years: Maximum serum creatinine 1 mg\u002FdL (male), 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years: Maximum serum creatinine 1.2 mg\u002FdL (male), 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years: Maximum serum creatinine 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n  * ≥ 16 years: Maximum serum creatinine 1.7 mg\u002FdL (male),1.4 mg\u002FdL (female)\n* OR a 24-hour urine Creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n* OR a glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).\n\n  * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.\n* Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible. However, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (ie, percutaneous nephrostomies or ureteric stents) of the urinary tract.\n\nFor adult patients (aged 18 years or older):\n\n* Creatinine clearance ≥ 50 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or as a 24-hour urine collection. Estimated creatinine clearance is based on actual body weight.\n\n(All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * If there is evidence of biliary obstruction by tumor, then total bilirubin must be \\\u003C 3 x ULN for age\n* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Patients with evidence of uncontrolled infection are not eligible\n* Previous or concurrent cancer(s) that is\u002Fwas being treated with chemotherapy and\u002For radiation.\n\n  * Note: Surgical resection alone of previous or concurrent cancer(s) is allowed\n* Patients with central nervous system involvement of RMS as defined below:\n\n  * Malignant cells detected in cerebrospinal fluid\n  * Intra-parenchymal brain metastases separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed)\n  * Diffuse leptomeningeal disease\n* Patients with known Charcot-Marie-Tooth disease\n* Patients who have received any chemotherapy (excluding steroids) and\u002For radiation therapy for RMS prior to enrollment. Note: the following exception:\n\n  * Patients requiring emergency radiation therapy for life-threatening complications of tumor burden due to RMS. These patients are eligible, provided they are consented to ARST2531 prior to administration of radiation.\n  * Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (eg, autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","50 Years",{"count":592,"type":21},342,[594],"PHASE3","This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.",[30],"2026-03-11",{"date":599,"type":41},"2026-03-12",{"date":601,"type":21},"2026-06-22",{"date":603,"type":21},"2031-03-31",{"name":605,"class":606},"Children's Oncology Group","NETWORK",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":613,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":622,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":49},"100570611","phase-1-phase-12-trial-to-evaluate-the-safety-and-efficacy-of-peel-224-in-combination-with-vincristine-and-temozolomide-in-adolescents-and-young-adults-with-relapsed-or-refractory-sarcomas-100570611","NCT06709495","Phase 1\u002F2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas","Inclusion Criteria:\n\n-Patients in all cohorts must have relapsed or refractory disease after standard therapy.\n\nInclusion Criteria Phase 1 (only) diagnosis requirements:\n\n-Patients must have:\n\n* Evaluable or measurable disease; and\n* Histologic diagnosis of sarcoma\n\nInclusion Criteria Phase 2 (only) diagnosis requirements\n\n* EWS cohort: Patients must have:\n\n  * RECIST measurable disease at study entry;\n  * Histologic diagnosis consistent with Ewing sarcoma; and\n  * Molecular evidence of a FET-ETS family translocation including but not limited to any of the following:\n\n    * EWSR1::FLI1, EWSR1::ERG, EWSR1::ETV1, EWSR1::ETV4, EWSR1::FEV, FUS::FLI1, FUS::ERG\n* DSRCT cohort: Patients must have:\n\n  * RECIST measurable disease at study entry;\n  * Histologic diagnosis consistent with DSRCT; and\n  * Molecular evidence of an EWSR1::WT1 fusion\n* Other sarcoma cohort: Patients must have:\n\n  * RECIST evaluable or measurable disease; and\n  * Histologic diagnosis of sarcoma. Patients with EWS or DSRCT with evaluable but not measurable disease may participate in this cohort.\n  * Slots in this cohort will include three dedicated slots for patients with rhabdomyosarcoma, three dedicated slots for patients with osteosarcoma and three dedicated slots for patients with other translocation-associated round cell sarcomas.\n* Age: ≥ 12 years and ≤ 49 years.\n* Weight: Patients must be ≥ 40 kg.\n* Performance Status: Karnofsky ≥ 50% for patients \\>16 year of age and Lansky ≥ 50% for patients ≤ 16 years of age. (see Appendix A for definitions of Lansky and Karnofsky Performance Status).\n* Participants must meet the following organ and marrow function as defined below: Adequate Bone Marrow Function:\n\n  * Hematologic Requirements for Subjects without Bone Marrow Involvement by\n\nDisease:\n\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FuL\n* Platelet count ≥100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n\n  --Hematologic Requirements for Subjects with Bone Marrow Involvement by Disease:\n* ANC ≥750 \u002FuL\n* Platelets ≥50,000 \u002FuL (may receive platelet transfusions) Not known to be refractory to red cell and\u002For platelet transfusions.\n\n  --Adequate Renal Function: Creatinine clearance or radioisotope GFR ≥70ml\u002Fmin\u002F1.73 m2 or A serum creatinine based on age\u002Fsex as follows:\n* Age: 12 to \\\u003C 13 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.2, Female 1.2\n* Age 13 to \\\u003C 16 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.5, Female 1.4\n\n  ---≥ 16 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.7, Female 1.4\n\n  --Adequate Liver Function:\n* Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age\n* SGPT (ALT) ≤110 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n\n  * Adequate Cardiac Function: QTc \\\u003C 480 msec\n\n    -Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted above. Patients must meet the following minimum washout periods prior to enrollment:\n  * Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy\n  * Radiotherapy:\n* At least 14 days after local XRT (small port, including cranial radiation);\n* At least 90 days must have elapsed after prior TBI, craniospinal XRT or if \\>50% radiation of pelvis;\n* At least 42 days must have elapsed if other substantial BM radiation.\n\n  * Small molecule biologic therapy: At least 7 days following the last dose of a biologic agent.\n  * Monoclonal antibody: At least 21 days must have elapsed after the last dose of antibody.\n  * Myeloid and platelet growth factors: At least 14 days following the last dose of long-acting myeloid growth factor (e.g. Neulasta) or 7 days following short-acting myeloid or platelet growth factor.\n  * Autologous hematopoietic stem cell transplant and stem cell boost: Patients must be at least 60 days from day 0 of an autologous stem cell transplant or stem cell boost.\n  * Cellular Therapies (e.g., CART, NK-cell based therapy): The patient must be and at least 42 days from cellular therapy administration.\n  * Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Biopsy, CNS shunt placement\u002Frevision, and central line placement\u002Fremoval are not considered major.\n  * Irinotecan, liposomal irinotecan, and\u002For temozolomide: Patients may have received prior irinotecan, liposomal irinotecan, and\u002For temozolomide. NOTE: Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.\n\n    -For patients with metastatic disease to the CNS enrolling to the phase 1 portion of the trial or the \"other sarcoma\" cohort, any baseline neurologic deficits (including seizure) must be stable for at least one week prior to study enrollment. Patients with CNS metastatic disease receiving corticosteroids must be on a stable or decreasing dose at time of study entry.\n  * Patients with CNS metastatic disease will not be eligible for the phase 2 EWS and DSRCT cohorts.\n\n    * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n    * The effects of PEEL-224 in combination with temozolomide and vincristine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of PEEL-224 administration.\n    * Ability to understand and\u002For the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedure.\n    * Any participant must obtain prior approval from insurance to reimburse oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide.\n\nExclusion Criteria:\n\n* Patients who have received prior treatment with PEEL-224.\n* Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.\n* Participants who are receiving any other anti-cancer agents for this condition.\n* Patients receiving strong P450 CYP1A2 and CYP3A4 inhibitors and\u002For inducers with 14 days of the first planned dose of PEEL-224. NOTE: levofloxacin is permitted and preferred over ciprofloxacin for patients needing a fluoroquinolone.\n* Patients who have received a solid organ or allogeneic stem cell transplant\n* Pregnant participants, given that the effects of PEEL-224 on the developing human fetus are unknown.\n* Breastfeeding mothers, because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with PEEL-224.\n* Patients with a history of allergic reactions attributed to PEGylated drugs, camptothecins, temozolomide or vincristine.\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","12 Years","49 Years",{"count":616,"type":21},63,[88,89],"This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.\n\nThe names of the study drugs and biological agents involved in this study are:\n\n* PEEL-224 (a type of Topoisomerase 1 inhibitor)\n* Vincristine (A type of vinca alkaloid)\n* Temozolomide (A type of alkylating agent)\n* Pegfilgrastim or Filgrastim (types of Myeloid growth factors)",[454,620,120,621,62,30],"Sarcoma, Ewing","Refractory Sarcoma",[454,620,120,621,623,624,625],"Relapsed Sarcoma","osteosarcoma","rhabdomyosarcoma","2026-02-17",{"date":628,"type":41},"2026-02-19",{"date":630,"type":41},"2025-01-27",{"date":632,"type":21},"2029-09-01",{"name":634,"class":48},"David S Shulman, MD",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":652,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":76},"100604325","phase-1-immunotherapy-for-solid-tumor-malignancies-in-pediatrics-using-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-t-cells-100604325","NCT07148050","Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells","IMPACT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Lansky or Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Lansky or Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n\n  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.","26 Years",{"count":644,"type":21},21,[88],"This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nA child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[648,649,511,512,93,30,650,125,651,332],"Solid Tumor (Excluding CNS)","Liver Cell Carcinoma","Embryonal Sarcoma of Liver","Hepatocellular Carcinoma",[653,32,654,655,510,276,515,516],"CAR T cell","Young Adult","Non-CNS Tumor","2026-02-13",{"date":626,"type":41},{"date":659,"type":41},"2025-12-22",{"date":661,"type":21},"2044-04-22",{"name":663,"class":48},"Seattle Children's Hospital",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":110,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":76},"100438877","phase-1-her2-chimeric-antigen-receptor-car-t-cells-in-combination-with-checkpoint-blockade-in-patients-with-advanced-sarcoma-100438877","NCT04995003","HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma","Phase I Study of HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma (HEROS 3.0)","Procurement Inclusion Criteria:\n\n* Diagnosis of a HER2-positive sarcoma. Immunohistochemistry (IHC) will be used to determine HER2 expression. Standard HER2 positive breast cancer density gradient tissue microarrays will be used as positive controls. HER2 expression will be graded for percent positive tumor cells (Grade 0: no staining; Grade 1: 1-25%; Grade 2: 26-50% and Grade 3: 51-100%) and intensity of staining (Negative; 1+; 2+; and 3+). For the patient to meet eligibility, tumors are required to have at least ≥ grade 1 and ≥ 1+ intensity score for HER2 staining.\n* Age between 1 to 25 years\n* Karnofsky or Lansky performance score of ≥ 60\n* Informed consent explained to, understood by, and signed by patient\u002Fguardian. Patient or guardian given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n* Diagnosis of a HER2 positive sarcoma with active disease progression or recurrence after at least one prior systemic therapy\n* At least 4 weeks from and having recovered from acute toxic effects of all prior cytotoxic chemotherapy. Those receiving targeted (non-cytotoxic) drugs must be at least 7 days or 3 drug half-lives, whichever is greater, from last receipt of said drug and must have recovered from all acute toxic effects of that drug.\n* Normal cardiac left ventricular end diastolic function (LVEF) as measured by echocardiogram (normal per institutional limits)\n* Karnofsky or Lansky performance score of ≥60\n* Total bilirubin ≤1.5x upper limit of normal (ULN) for age AND direct bilirubin ≤ULN for age\n* AST\u002FALT ≤ 2.5x ULN\n* Serum creatinine ≤1.5x ULN for age\n* Hgb ≥ 7.0 g\u002FdL (transfusion allowed)\n* WBC \\> 2,000\u002Fµl\n* ANC \\>1,000\u002Ful\n* Platelets \\>75,000\u002Ful (not transfused)\n* Pulse oximetry of ≥ 90% on room air\n* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. Non-childbearing potential is defined as pre-menarche, greater than 1-year post-menopausal, or surgically sterilized.\n* Available autologous transduced cytotoxic T lymphocytes with ≥ 15% expression of HER2 CAR and killing of HER2-positive targets ≥ 20% in cytotoxicity assay\n* Informed consent explained to, understood by, and signed by patient or guardian. Patient or guardian given copy of informed consent.\n\nProcurement Exclusion Criteria:\n\n* Known HIV positivity\n* Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis\n* Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients\n* History of allergic reactions attributed to murine protein containing products, DMSO or dextran 40\n* Known, active cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically significant cardiac arrhythmia.\n\nNote: A new echocardiogram or EKG is not required to make this determination.\n\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* History of non-infectious pneumonitis that required steroids or current pneumonitis\n* Known history of active tuberculosis\n* Has undergone solid organ transplantation at any time\n* Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy aside from cytotoxic chemotherapy\n* Presence of bulky tumor at the primary or metastatic site\n* Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator\n\nTreatment Exclusion Criteria:\n\n* Known HIV positivity\n* Intercurrent infection\n* Pregnant or lactating\n* History of hypersensitivity to murine protein-containing products, DMSO or dextran 40\n* Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis\n* Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients\n* Cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically significant cardiac arrhythmia\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of non-infectious pneumonitis that required steroids or current pneumonitis\n* Known history of active tuberculosis\n* Has received a live virus vaccine within previous 30 days\n* Has undergone solid organ transplantation at any time\n* Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy\n* Presence of bulky tumor at the primary or metastatic site\n* Has received radiotherapy within 14 days of start of trial treatment with the exception that those who have received palliative radiation (≤ 10 days of radiotherapy) to non-central nervous system disease within 7 days are permitted. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator",{"count":7,"type":21},[88],"The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma.\n\nAnother goal of this study is to study the bacteria found in the stool of patients with sarcoma who are being treated with HER2 CAR T cells and immune checkpoint inhibitor drugs to see if the types of bacteria influence how well the treatment works.\n\nThe investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to see if they can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that the investigators will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition, it contains CD28, which stimulated T cells and make them last longer. After this new gene is put into the T cell, the T cell becomes known as a chimeric antigen receptor T cell or CAR T cell.\n\nIn another clinical study using these CAR T cells targeting HER2 as well as other studies using CAR T cells, investigators found that giving chemotherapy before the T cell infusion can improve the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of the patient's lymphocytes first should allow the infused T cells to expand in the body, and potentially kill cancer cells more effectively.\n\nThe chemotherapy used for lymphodepletion is a combination of cyclophosphamide and fludarabine.\n\nAfter the patient receives the lymphodepletion chemotherapy and CAR T cells during treatment on the study, they will receive an antibody drug called an immune checkpoint inhibitor, pembrolizumab or nivolumab. Immune checkpoint inhibitors are drugs that remove the brakes on the immune system to allow it to act against cancer.",[454,675,62,30,29,116,65,676],"HER-2 Protein Overexpression","Undifferentiated Sarcoma",[454,678,679,680,681,62,30,33,682,683,684],"Her-2 Positive Sarcoma","autologous T cells","HER2 positive recurrent or progressive sarcoma","HER2 CAR T cells","Synovial sarcoma","Soft tissue sarcoma","Undifferentiated sarcoma","2026-01-21",{"date":687,"type":41},"2026-01-22",{"date":689,"type":41},"2021-12-07",{"date":691,"type":21},"2043-06-30",{"name":525,"class":48},{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":698,"acronym":4,"eligibilityCriteria":699,"healthyVolunteers":12,"sex":17,"minAge":700,"maxAge":701,"enrollmentInfo":702,"targetDuration":4,"studyType":22,"phases":704,"briefSummary":705,"conditions":706,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":76},"100620302","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-all-trans-retinoic-acid-combined-with-vac-regimen-in-the-treatment-of-intermediate-to-high-risk-rhabdomyosarcoma-100620302","NCT07355855","A Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma","A Multicenter, Multi-cohort, Prospective Phase II Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma","Inclusion Criteria:\n\n1. Age ≥ 14 years old and ≤ 60 years old;\n2. Histologically confirmed medium to high risk rhabdomyosarcoma (excluding pleomorphic rhabdomyosarcoma);\n3. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0-1;\n4. Have not received any anti-tumor drug treatment in the past;\n5. Expected survival time ≥ 3 months;\n6. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests), as follows Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 100 g\u002FL (no transfusion or erythropoietin dependence within 14 days) Liver function: serum total bilirubin ≤ 1.25 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN (≤ 5x ULN for patients with liver metastases); Serum albumin ≥ 30 g\u002FL; Alkaline phosphatase (ALP) ≤ 5 × ULN.\n\n   Renal function: Serum creatinine (Cr) ≤ 1.25 × ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin (using the standard Cockcroft Gault formula): Urine routine results show urinary protein\\\u003C2+; For patients whose baseline urine routine test shows urinary protein ≥ 2+, 24-hour urine collection should be performed with a 24-hour urine protein quantification of\\\u003C1g.\n\n   Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of use of the anticoagulant drug.\n7. For female subjects of childbearing age, a urine or serum pregnancy test should be conducted 3 days before receiving the first study drug and the result should be negative;\n8. Participants and their sexual partners are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment period.\n\nExclusion Criteria:\n\n1. Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;\n2. Subjects who cannot accept or tolerate this chemotherapy regimen for various reasons;\n3. Biopsy confirmed a patient with bone marrow infiltration;\n4. Patients who have undergone major surgical procedures unrelated to medium to high risk rhabdomyosarcoma within the 4 weeks prior to enrollment, or who have not fully recovered from such surgical procedures;\n5. Serious heart disease or discomfort, including but not limited to the following diseases:\n\n   * Diagnosed history of heart failure or systolic dysfunction (LVEF\\\u003C50%);\n   * High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\\>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block);\n   * Angina requiring treatment with anti angina drugs;\n   * Clinically significant heart valve disease;\n   * ECG shows transmural myocardial infarction;\n   * Poor control of hypertension (systolic blood pressure\\>180mmHg and\u002For diastolic blood pressure\\>100mmHg)\n6. Individuals with a known history of allergies to the components of this medication regimen;\n7. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.","14 Years","60 Years",{"count":703,"type":21},106,[89],"This study is a prospective, multi-cohort, multi-center clinical trial targeting patients with intermediate-to-high-risk rhabdomyosarcoma who have not previously received systemic anti-tumor treatment. It aims to evaluate the efficacy and safety of all-trans retinoic acid combined with VAC chemotherapy.",[30],"2026-01-13",{"date":685,"type":41},{"date":710,"type":21},"2026-01",{"date":712,"type":21},"2029-01",{"name":714,"class":48},"Fudan University",{"id":716,"slug":717,"hasResults":12,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":721,"eligibilityCriteria":722,"healthyVolunteers":12,"sex":17,"minAge":323,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":22,"phases":724,"briefSummary":725,"conditions":726,"keywords":727,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":729,"lastUpdatePostDateStruct":730,"startDateStruct":732,"completionDateStruct":733,"leadSponsor":735,"locationsCount":76},"100610206","phase-1-cytokine-armored-gpc3-specific-chimeric-antigen-receptor-expressing-t-cells-in-adults-with-solid-tumors-100610206","NCT07224568","Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors","INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors","INTERCEPT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh-Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* 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* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n  * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)",{"count":644,"type":21},[88],"This Phase 1, open-label, non-randomized study will enroll adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nAn adult participant meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[648,651,649,93,512,30],[653,728,655,510,276,515,516],"Adult","2025-10-31",{"date":731,"type":41},"2025-11-04",{"date":517,"type":21},{"date":734,"type":21},"2045-08",{"name":663,"class":48}]