[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-osteosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-osteosarcoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100493338","phase-1-study-of-car70-engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-advanced-renal-cell-carcinoma-mesothelioma-and-osteosarcoma-100493338",false,"NCT05703854","Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma","Phase I\u002FII Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma","Inclusion Criteria:\n\nPatients must meet the following criteria for study entry:\n\n* Patients with advanced clear cell renal cell carcinoma, osteosarcoma or mesothelioma, with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry for clear cell renal cell carcinoma and mesothelioma, or ≥ 1% for osteosarcoma.\n* Patients must meet disease-specific eligibility criteria (see below).\n* Patients must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinase inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy.\n* Patients must be at least 3 months from any cell therapy for malignancy.\n* Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, provided that there are additional measurable non-irradiated disease sites.\n* Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for patients \\> 16 years of age or Lansky for patients ≤ 16 years of age, see Appendix A).\n* Adequate organ function at screening, as defined by the following:\n\n  1. Renal: Serum creatinine ≤ 1.5 mg\u002FdL or estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥30 ml\u002Fmin\u002F1.73 m2\n  2. Hepatic: alanine transaminase (ALT)\u002Faspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg\u002FdL or ≤ 3.0 mg\u002FdL for patients with Gilbert's Syndrome. No history of liver cirrhosis and no ascites.\n  3. Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)\n  4. Pulmonary: No clinically significant pleural effusion (per principal investigator \\[PI\\] judgement), and baseline oxygen saturation ≥ 92% on room air. Subjects with active interstitial lung disease (ILD)\u002Fpneumonitis requiring treatment with systemic steroids will be excluded.\n  5. Hematological: absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, platelet count ≥ 75,000\u002Fmm3, and hemoglobin ≥ 8 g\u002FdL. For patients with human immunodeficiency virus infection, CD4+ T-cell (CD4+) counts must be ≥ 350 cells\u002FuL.\n  6. Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and\u002For aPTT ≤ the upper limit of the therapeutic range for intended use.\n* Able to provide written informed consent and if applicable pediatric assent.\n* Aged 16-80 years.\n* Weight ≥40 kg.\n* All male and female patients who are able to have children must practice effective birth control while on study therapy and for up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Female patients who become pregnant or suspect pregnancy must immediately notify their doctor. Females patients who become pregnant will be taken off study. Men who are able to have children must use effective birth control while on the study therapy. Acceptable forms of birth control for male patients include: condom with spermicide or abstinence. If the male patient fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n* Negative serum or urine beta human chorionic gonadotropin pregnancy test for females of childbearing potential (defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females) at screening.\n* Signed consent to long-term follow-up on protocol PA17-0483.\n\nDisease-specific inclusion criteria\n\n* Renal Cell Carcinoma\n\n  1. Patients must have a histologically confirmed diagnosis of Stage 4 RCC with a clear cell component.\n  2. Patients must have received at least 1 prior line of therapy for recurrent or metastatic disease, including both PD-1\u002Fprogrammed cell death-ligand 1 immunotherapy and anti-angiogenic-directed treatment, such as a tyrosine kinase inhibitor. Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal.\n  3. Patients must have at least 1 measurable lesion \\>10 mm on computed tomography (CT) per the RECIST v1.1.\n* Mesothelioma\n\n  1. Patients must have pathologically confirmed mesothelioma\n  2. Patients must have progressive, recurrent, or refractory disease (local recurrence) or new disease after all curative measures, including first-line chemotherapy, targeted therapy, and radiotherapy. Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal.\n  3. Patients must have measurable or evaluable disease per the RECIST v1.1 at enrollment.\n* Osteosarcoma\n\n  1. Patients must have histologically confirmed osteosarcoma that is recurrent or refractory and for which standard curative measures do not exist or are no longer effective. The patient must have received at least one chemotherapy regimen based on anthracycline, if no contra-indication to this class of drug. Must have histologic verification of their disease at diagnosis or at relapse.\n  2. Patients must have at least:\n\n     * Progressive, recurrent, or refractory disease (local recurrence) or new disease after all curative measures, including first-line chemotherapy, targeted therapy, and radiotherapy.\n     * Evidence of persistent and progressive disease on imaging, which may include fludeoxyglucose F-18 positron emission tomography (PET)-avid metastasis, that has failed to achieve CR to upfront conventional therapy (surgery, chemotherapy), excluding lung metastases amenable to surgical resection.\n  3. Patients must have evaluable or measurable disease per the RECIST v1.1 at enrollment.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n* Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated with the previous anticancer treatment, as determined by the PI. Toxicities related to prior surgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.\n* Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n* Known active hepatitis B or C.\n* Known human immunodeficiency virus with detectable viral load. Patients with undetectable viral load may be excluded in case the antiretroviral drug cannot be co-administered with the lymphodepleting chemotherapy and cannot be changed\u002Ftemporarily suspended, according to PI evaluation.\n* Presence of active neurological disorder(s).\n* Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).\n* Amyloidosis or POEMS syndrome.\n* Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days.\n* Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or active non-life-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the patient's ability to participate and\u002For complete this trial. Examples include but are not limited to: urothelial cancer Grade Ta or T1 and adenocarcinoma of the prostate treated by active surveillance.\n* Presence of any other serious medical condition that may endanger the patient at investigator's discretion, including but not limited to:\n\n  * New York Heart Association Class III or IV heart failure\n  * Myocardial infarction or stroke ≤ 26 weeks prior to CAR.70 NK cell infusion\n  * Unstable angina within ≤ 13 weeks prior to CAR.70 NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)\n  * Severe aortic stenosis\n  * Uncontrolled arrhythmia. PI approval is required for patients with arrhythmia who may be included as an exception.\n  * Congenital long QT syndrome. PI approval is required.\n  * Documentation, during the screening process, of a QTc \\> 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of each other. The patient should be reclining for 5 minutes prior to ECGs. Local readings may be used for this exclusion criterion.\n* Major surgery \\\u003C 4 weeks prior to first dose of lymphodepleting chemotherapy.\n* Concomitant use of other investigational agents.\n* Concomitant use of other anticancer agents.\n* Previously received any anti-CD70 therapy.\n* Patients receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone daily (physiological substitutive doses are allowed).\n* Received antithymocyte globulin within 14 days or Campath within 28 days of enrollment.\n* Patients receiving immunosuppressive therapy.\n* Pregnant or breastfeeding.","ALL","16 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","To find a recommended dose of donated NK cells that can be given with lymphodepleting chemotherapy to patients with advanced renal cell carcinoma, mesothelioma, or osteosarcoma. The effects of this therapy will also be studied.",[28,29,30],"Advanced Renal Cell Carcinoma","Advanced Mesothelioma","Advanced Osteosarcoma","RECRUITING","2026-03-02",{"date":34,"type":35},"2026-03-04","ACTUAL",{"date":37,"type":35},"2023-03-29",{"date":39,"type":21},"2027-09-30",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100610437","phase-1-genetically-engineered-cells-fh-folr1-st-car-t-cells-for-the-treatment-of-advanced-refractory-or-recurrentprogressive-osteosarcoma-fierce-trial-100610437","NCT07227571","Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent\u002FProgressive Osteosarcoma, FIERCe Trial","FIERCe: FOLR1 Immune Effector Cell Therapy Against Advanced Osteosarcoma","Inclusion Criteria:\n\n* Age 1-75 years at the time of enrollment\n* Tissue confirmation of osteosarcoma diagnosis\n* Must have received an anthracycline-based regimen or been deemed ineligible to receive this therapy\n* Must have at least one of the following in the 6 months prior to trial consent:\n\n  * New site of measurable disease by radiographic imaging or histologic confirmation\n  * New site of evaluable disease by radiographic imaging or histologic confirmation\n  * Greater than 20% increase in at least one tumor dimension documented by CT\u002FMRI, AND a minimum absolute increase of 5 mm in longest dimension of existing lesion(s) (previously irradiated lesions may be included)\n  * Persistent measurable disease or fludeoxyglucose F-18 (FDG)-PET avid bone metastasis that has failed to achieve complete remission to upfront conventional therapy (surgery, radiotherapy, and\u002For chemotherapy)\n* All anti-cancer therapy must be discontinued at enrollment\u002Ftime of apheresis, with the following washout periods observed:\n\n  * Chemotherapy and biologic agents: ≥ 7 days prior to enrollment\n  * Steroid use: All corticosteroid therapy (unless physiologic replacement dosing and\u002For topical administration (e.g., inhaled or dermatologic) ≥ 7 days prior to enrollment\n  * Tyrosine kinase inhibitor (TKI) use: ≥ 7 days prior to enrollment\n  * Antitumor antibody therapy (including immune checkpoint inhibitor) must be ≥ 3 half-lives or 30 days, whichever is shorter, from time of enrollment\n  * FOLR1 targeting therapy must be discontinued at least 30 days prior to enrollment\n  * Gene modified cellular therapy: At enrollment, must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR must be at least 60 days from most recent gene modified cell therapy\n  * Washout periods not applicable to patients with apheresis product or usable T cell product available for use at time of enrollment\n* Potential trial participants should have recovered to grade 1 from clinically significant adverse events of their most recent therapy\u002Fintervention prior to enrollment\n* Ability to understand and willingness to sign a written informed consent document.\n* Females of child-bearing potential and fertile male participants must be willing to use an effective contraceptive method before, during, and for at least 12 months after the FOLR1 CART cell infusion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (if treated at adult facility) or Lansky\u002FKarnofsky score ≥ 60 (if treated at pediatric facility). Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status\n* Life expectancy ≥ 8 weeks\n* Able to tolerate apheresis, including placement of temporary apheresis catheter, if necessary, or already has an apheresis product available for use in manufacturing\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* Participants with treated brain metastases are eligible if they meet the following criteria:\n\n  * Follow-up brain imaging taken at screening demonstrates no evidence of progression and that imaging occurs 3 months after central nervous system (CNS)-directed therapy has been completed\n  * No ongoing, symptomatic CNS pathology requiring medical intervention\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) based on age and gender; or estimated creatinine clearance \\> 50 mL\u002Fmin as calculated using the Cockcroft-Gault formula and not dialysis dependent\n\n  * Age: 1 to \\\u003C 2 years; maximum serum creatinine (mg\u002FdL): 0.6 (male), 0.6 (female)\n  * Age: 2 to \\\u003C 6 years; maximum serum creatinine (mg\u002FdL): 0.8 (male), 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; maximum serum creatinine (mg\u002FdL): 1 (male), 1 (female)\n  * Age: 10 to \\\u003C 13 years; maximum serum creatinine (mg\u002FdL): 1.2 (male), 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; maximum serum creatinine (mg\u002FdL): 1.5 (male), 1.4 (female)\n  * Age: ≥ 16 years; maximum serum creatinine (mg\u002FdL): 1.7 (male), 1.4 (female)\n* Total bilirubin ≤ 3 x ULN or conjugated bilirubin ≤ 2 mg\u002FdL. Participants with suspected Gilbert syndrome may be included if total bilirubin (Bili) \\> 3 mg\u002FdL but no other evidence of hepatic dysfunction\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* Pulmonary: ≤ grade 1 dyspnea at rest and arterial oxygen saturation (SaO2) ≥ 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) ≥ 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of ≥ 40% of predicted will be eligible\n* Left ventricular ejection fraction (LVEF) may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 50% or shortening fraction ≥ 28%\n* Absolute neutrophil count (ANC) ≥ 500 cells\u002F mm\\^3\n* Hemoglobin ≥ 8 g\u002FdL\n* Platelets ≥ 100,000 per mm\\^3\n* Participants receiving blood product transfusion are acceptable as long as they are not determined to be transfusion refractory\n\nExclusion Criteria:\n\n* Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by PI\n* Corticosteroid therapy at a dose equivalent of \\> 15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable. For participants weighing ≤ 30 kg, systemic steroids ≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday\n* Concurrent use of other investigational anti-cancer agents\n* Active uncontrolled infection: HIV positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm\\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication\n* Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements\n* Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of \\> 15 mg prednisone (or equivalent) per day, unless otherwise approved by PI\n* Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Pregnant, possibly pregnant or those expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion\n* Participants unwilling to provide consent\u002Fassent for participation in the study and 15-year follow-up period if CAR T cell therapy is administered\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments","1 Year","75 Years",{"count":54,"type":21},30,[24],"This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 ST chimeric antigen receptor (CAR) T cells and how well they work in treating patients with osteosarcoma that recurred or spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has not responded to previous treatment (refractory) or has come back after a period of improvement (recurrent)\u002Fis growing, spreading, or getting worse (progressive). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they attack tumor cells. T cells are taken from a patient's blood through a process called apheresis. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells, such as FOLR1, is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by an intravenous infusion. Chemotherapy drugs, such as fludarabine and cyclophosphamide, are given to a patient before the manufactured FH-FOLR1 ST CAR T cells to make room for the CAR T cells in the blood and to enhance the CAR T cell activity in the patient. FH-FOLR1 ST CAR T cells may be safe, tolerable, and\u002For effective in treating patients with advanced refractory or recurrent\u002Fprogressive osteosarcoma.",[30,58,59],"Recurrent Osteosarcoma","Refractory Osteosarcoma",[61],"Bones and Joints","2026-02-09",{"date":64,"type":35},"2026-02-11",{"date":66,"type":35},"2026-01-16",{"date":68,"type":21},"2044-01-31",{"name":70,"class":42},"Fred Hutchinson Cancer Center"]