[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-osteosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-osteosarcoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100609221","phase-1-nkg2dzeta-nk-cell-conditioning-with-c7rgd2car-t-cells-for-patients-with-relapsed-or-refractory-osteosarcoma-or-neuroblastoma-100609221",false,"NCT07211737","NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma","(INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma","PROCUREMENT INCLUSION:\n\n1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n\n   Or\n\n   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n2. Karnofsky\u002FLansky score of 60% or greater.\n3. Informed consent and assent (as applicable) obtained from parent\u002Fguardian and child.\n4. Greater than 1 year of age.\n\nPROCUREMENT EXCLUSION:\n\n1. History of hypersensitivity to murine protein-containing products.\n2. Known presence of Human Anti-Mouse Antibodies (HAMA).\n3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).\n4. Primary brain tumor or known brain metastases (on evaluation by MIBG and\u002For PET if applicable, CT\u002FMRI\u002FLP not required).\n\nTREATMENT INCLUSION:\n\n1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n\n   Or\n\n   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n2. Karnofsky\u002FLansky score of 50% or greater\n3. Pulse Ox greater than or equal to 90% on room air\n4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)\n5. Total bilirubin less than 3 times the upper limit of normal\n6. Serum creatinine less than 3 times upper limit of normal\n7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR\n8. Informed consent and assent (as applicable) obtained from parent\u002Fguardian and child.\n9. Greater than 1 year of age.\n10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.\n\nTREATMENT EXCLUSION:\n\n1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).\n2. Known presence of Human Anti-Mouse Antibodies (HAMA).\n3. Tumor potentially causing airway obstruction per investigator discretion.\n4. Pregnancy or lactation \u002F will not use birth control methods.\n5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg\u002Fkg\u002Fday of prednisone\u002Fequivalent).\n6. Primary brain tumor or known brain metastases (on evaluation by MIBG and\u002For PET if applicable, CT\u002FMRI\u002FLP not required).","ALL","1 Year","24 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer.\n\nPatients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection.\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: NK cells and T cells. T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. NK cells, another kind of infection-fighting cell, can recognize a wide range of cells in distress, including tumor cells and cells that help protect tumor cells in the cancer environment. Both NK cells and T cells have been used individually to treat patients with cancers. They have shown promise, but have not been strong enough individually to cure most patients.\n\nInvestigators have found from previous research that we can put a new gene into T cells that will make them recognize GD2, a substance found on almost all neuroblastoma and osteosarcoma cells. We can also put a new gene into NK cells that help them fight the tumor environment. Investigators know that T cells and NK cells need substances called cytokines to survive but the cells do not get enough cytokines after infusion into the body; therefore, the investigators have added the genes C7R and IL15 into the T and NK cells, respectively, to give each cell a constant supply of cytokine that helps them to survive longer.\n\nThe C7R.GD2.CAR-T cells and i15.NKG2D.zeta-NK cells are investigational products not approved by the Food and Drug Administration.",[27,28,29,30],"Relapsed Neuroblastoma","Refractory Neuroblastoma","Relapsed Osteosarcoma","Refractory Osteosarcoma",[32,33,34,35,36,37,38],"Gene Therapy","CAR T cells","Neuroblastoma","Osteosarcoma","Immunotherapy","chimeric antigen receptor","NK Cell","NOT_YET_RECRUITING","2026-06-30",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":21},"2026-08",{"date":47,"type":21},"2044-04",{"name":49,"class":50},"Baylor College of Medicine","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":51},"100604033","phase-1-tegavivint-with-gemcitabine-in-patients-with-relapsed-or-refractory-osteosarcoma-100604033","NCT07144254","Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma","Study of Tegavivint, a Transducin Beta-like Protein 1 (TBL1) Inhibitor, With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma","Inclusion Criteria:\n\nDiagnosis:\n\nParticipants must have had histologic verification of osteosarcoma at original diagnosis or relapse.\n\n* All participants with relapsed or refractory osteosarcoma are eligible, provided they received front-line treatment with a regimen that contained at least 3 of the following agents: methotrexate, doxorubicin, cisplatin, and ifosfamide\n\n  -Disease Status:\n* Dose Escalation: Participants must have either measurable or evaluable disease per RECIST.Note: Participants with no evidence of disease on imaging (e.g., following pulmonary metastasectomy) are not eligible during the dose escalation phase.\n* Dose Expansion: Participants with measurable or evaluable disease per RECIST and those with no evidence of disease on imaging following pulmonary metastasectomy are eligible during the dose expansion phase.\n\n  -Performance Level: Participants must have a Lansky (≤ 16 years) or Karnofsky (\\> 16 years) score of ≥ 60, or Eastern Cooperative Oncology Group (ECOG) ≤ 2 Note: Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory to assess the performance score.\n\n  -Prior Therapy: Participants must have fully recovered from the clinically significant acute effects of all prior anti-cancer chemotherapy, immunotherapy, surgery, or radiation therapy before enrollment.\n* Myelosuppressive chemotherapy: ≥ 14 days after the last dose.\n* Hematopoietic growth factors: ≥ 14 days after a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for a short-acting growth factor. For agents with known delayed adverse events, extend recovery period accordingly.\n* Biologic (anti-neoplastic) agent: ≥ 7 days after the last dose. Extend period if adverse events occur beyond 7 days.\n* Cellular therapy: ≥ 21 days since last dose (e.g., modified T cells, gamma-delta T cells, natural killer (NK) cells, dendritic cells) with recovery from associated toxicities.\n* Interleukins, interferons, and cytokines (excluding hematopoietic growth factors): ≥ 21 days since last dose.\n* Antibodies: 7 days or 3 half-lives (whichever is longer), up to 30 days. Toxicity must be resolved to Grade ≤ 1.\n* Radiation therapy (XRT):\n\n  * 14 days after local palliative XRT (small port)\n  * 150 days after radiation to ≥ 50% of pelvis or bone marrow\n  * 6 weeks after substantial bone marrow radiation\n\nPrior use of Nucleoside Analogue (Gemcitabine): Allowed. Investigational agents not otherwise specified: ≥ 30 days since last dose. Surgery: ≥ 2 weeks since last major surgery, including pulmonary metastasectomy (central line placement and core\u002Fsmall open biopsies are excluded)\n\nOrgan Function Requirements:\n\n* Adequate Bone Marrow Function Defined As:\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3 (0.75x109\u002FL)\n  * Platelet count ≥ 75,000\u002Fmm3 (75x109\u002FL)\n* Adequate Renal Function Defined As: Creatinine clearance or radioisotope GFR ≥ 70 ml\u002Fmin\u002F1.73 m2\n* Adequate Liver Function Defined As:\n\n  * Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x the upper limit of normal (ULN) for age\n  * ALT ≤ 5 x the ULN\n* Adequate Pulmonary Function Defined As: No dyspnea at rest, no exercise intolerance, and no oxygen requirement (pulse oximetry \\> 93% on room air).\n* Adequate Cardiac Function Defined As: QTc ≤ 470 ms using Fridericia formula\n\nExclusion Criteria:\n\n* CNS disease: Patients with a history of intraparenchymal CNS disease (osteosarcoma) are not eligible unless they have imaging documenting stability of CNS lesions for ≥ 3 months prior to enrollment\n* Pregnancy or Breast-Feeding\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained\n* Males or females of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method\n* Concomitant Medications:\n\n  * Investigational Drugs: Subjects who are currently receiving another investigational drug are not eligible.\n  * Anti-cancer Agents: Subjects who are currently receiving other anti-cancer agents are not eligible.\n  * CYP3A4\u002F5 Agents: Patients currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days before the 1st dose of tegavivint to the end of the study. See Appendix II for a list of agents.\n  * Bisphosphonates: Patients receiving bisphosphonates within 4 Weeks of study enrollment are not eligible.\n  * Denosumab: Patients who have received denosumab within 180 days prior to study enrollment are not eligible\n* Infection: Subjects who have an active, uncontrolled infection.\n* Subjects who have received prior solid organ or allogeneic stem cell transplantation.\n* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia).\n* Patients with a disorder associated with abnormal bone metabolism.\n* Patients with ≥ 2 grade hypocalcemia that is not corrected with oral calcium supplementation.\n* Patients with vitamin D \\\u003C 20 ng\u002FmL will require supplementation or will otherwise be excluded. Patients must agree to take vitamin D +\u002F- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained.\n* Patients who have previously received tegavivint are not eligible.","30 Years",{"count":61,"type":21},24,[24],"The goal of this clinical trial is to define the maximum tolerated dose (MTD) and\u002For Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS).\n\nThe study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.",[65,66,29,30],"Osteosarcoma Recurrent","Osteosarcoma in Children",[68,69,70,35],"Tegavivint","TBL1 inhibitor","Gemcitabine","RECRUITING","2026-05-30",{"date":74,"type":43},"2026-06-02",{"date":76,"type":43},"2026-01-22",{"date":78,"type":21},"2028-05",{"name":80,"class":50},"Emory University",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":51},"100470036","phase-1-allogeneic-expanded-gamma-delta-t-cells-with-gd2-chemoimmunotherapy-in-relapsed-refractory-neuroblastoma-or-refractory-relapsed-osteosarcoma-100470036","NCT05400603","Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed \u002FRefractory Neuroblastoma or Refractory\u002F Relapsed Osteosarcoma","A Phase I Study of Allogeneic Ex Vivo Expanded Gamma Delta (γδ) T Cells in Combination With Dinutuximab, Temozolomide, Irinotecan, and Zoledronate in Children With Refractory\u002F Relapsed, or Progressive Neuroblastoma or Refractory\u002F Relapsed Osteosarcoma","Aflac-NBL-2002","Inclusion Criteria:\n\n* Patients must be ≥ 12 months of age at the time of enrollment in the study.\n* Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. (Bone marrow samples with positive catecholamines are acceptable as confirmation of neuroblastoma) OR histological confirmation of osteosarcoma at diagnosis\n* Response to prior therapy:\n\n  * High-risk neuroblastoma with refractory, relapsed or progressive disease, defined as:\n  * First or greater relapse of neuroblastoma following completion of aggressive multi- drug frontline therapy.\n  * First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy.\n  * Persistent\u002Frefractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) after at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (such as A3973 or ANBL0532).\n  * Note that this excludes patients initially considered low or intermediate-risk neuroblastoma that progressed to high-risk disease but the patient has not progressed after the diagnosis of high-risk neuroblastoma.\n  * Relapsed or refractory osteosarcoma that is not responsive to standard treatment\n* Disease Status\n\n  * Patients must have measurable or evaluable disease per revised INRC for subjects with neuroblastoma or measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects with Osteosarcoma\n  * Performance Level:Patients must have a Lansky (≤16 years) or Karnofsky (\\>16 years) score of ≥50\n* Prior Therapy\n\n  * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before study registration.\n\n    * Prior dinutuximab therapy is allowed regardless of prior response or progression on dinutuximab\n    * Prior temozolomide therapy is allowed\n    * Prior zoledronate is allowed\n    * Prior dinutuximab\u002Ftemozolomide\u002Firinotecan chemoimmunotherapy is allowed\n    * Prior T cell therapy is excluded\n* Organ Function Requirements:\n\n  * Hematologic Functions : Absolute Neutrofil count ≥750\u002FuL and platelet count ≥ 75,000\u002Fµl, transfusion independent .\n  * Renal Function: Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age.\n  * Liver Function: Total bilirubin ≤ 1.5 x ULN for age and serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U\u002FL (≤ 3x ULN).\n  * Cardiac Function: Normal ejection fraction (≥ 55%) documented by either echocardiogram or radionuclide multigated acquisition scan (MUGA) evaluation OR Normal fractional shortening (≥ 27%) documented by echocardiogram\n  * Pulmonary Function: Normal pulmonary function with no evidence of dyspnea at rest, no exercise intolerance.\n\nExclusion Criteria:\n\n* Prior T cell therapy\n* Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study.\n* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Patients with known active Central Nervous System (CNS) disease (excluding skull disease with intracranial extension). Patients with a history of CNS disease are required to have a brain CT and\u002F or MRI at study registration.\n* Patients with prior allogeneic stem cell transplant\n* Patients who are on hemodialysis\n* Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Patients who have had to permanently discontinue Dinutuximab due to toxicity\n* Patients with serious, uncontrolled cardiac arrhythmias\n* Patients with a history of myocarditis\n* Patients who have received any live vaccines within 30 days before enrollment","12 Months",{"count":61,"type":21},[24],"The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory\u002F relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate",[34,28,27,29,30],[95,96,97,98,99,100,101],"Gamma Delta T Cells","Dinutuximab","Temozolomide","Zoledronate","Irinotecan","GD2","chemoimmunotherapy","2025-12-19",{"date":104,"type":43},"2025-12-26",{"date":106,"type":43},"2023-11-06",{"date":108,"type":21},"2026-12",{"name":80,"class":50}]