[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synovial-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synovial-sarcoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,59,85,114,141,170,192,218,235,257,291,320,349,384,427],{"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":42,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132",false,"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.","ALL","6 Months","25 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Neuroblastoma","Rhabdomyosarcoma","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","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[43,44,45],"pediatric solid tumors","stem cell transplantation","graft manipulation","RECRUITING","2026-06-25",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2030-02",{"name":56,"class":57},"University of Florida","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":58},"100613059","early-phase-1-n-803-in-patients-with-progressive-synovial-sarcoma-and-myxoidround-cell-liposarcoma-previously-treated-with-adoptive-cellular-therapy-100613059","NCT07261657","N-803 in Patients With Progressive Synovial Sarcoma and Myxoid\u002FRound Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy","A Pilot Trial of N-803 in Patients With Synovial Sarcoma and Myxoid\u002FRound Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed Synovial Sarcoma (SS) and\u002For Myxoid\u002FRound Cell Liposarcoma (MRCL) who have progressed after ACT using TCR-T.\n* Patients must have been treated with a TCR-T product that can be assessed per medical history and\u002For discretion of the principal investigator. This includes the FDA approved Afamitresgene autoleucel but also other products at the discretion of the principal investigator.\n\nNote on References to Letetresgene Autoleucel and Afamitresgene Autoleucel: This study does not involve active treatment with TCR-T cell therapies, including Letetresgene autoleucel or Afamitresgene autoleucel. The investigational drug of this study is N-803. Please see Section 4.3.3 for more information.\n\n* Patients must have measurable disease according to RECIST v1.1. See Appendix A for RECIST v1.1 criteria.\n* Patients must have shown clinical benefit on at least one scan post ACT using TCR-T, (SD, PR, CR), as determined by the treating investigator.\n* Patients must be aged ≥ 18 to 80 at time of registration.\n* Patients must have a performance status of \\>70% on the Karnofsky Scale (see Appendix A) or \\\u003C 2 on the ECOG Performance Scale (see Appendix B).\n* Patients must be able to undergo leukapheresis per institutional standards. For patients receiving leukapheresis at the Rube Walker Blood Center, see Appendix F for reference document guidance and Rube Walker Blood Center leukapheresis eligibility criteria.\n* Patients must have adequate organ and bone marrow function as defined below within screening window of 28 days up until Pre-Dose Leukapheresis:\n\nLaboratory Test Value\n\nAbsolute Neutrophil Count (ANC) ≥ 1,000\u002FmcL\\*\\* Hemoglobin (Hgb) ≥ 8.3 g\u002FdL Platelets (PLT) ≥ 40,000\u002FmcL Total bilirubin ≤ Institutional upper limit of normal (ULN)\\* AST (SGOT) ≤ 1.5 x institutional ULN ALT (SGPT) ≤ 1.5 x institutional ULN ALP (alkaline phosphatase) ≤ 2.5 institutional ULN Serum Creatinine ≤ 2.0 mg\u002FdL or 177 μmol\u002FL or creatinine clearance ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula below):\n\nCockcroft-Gault Formula:\n\nFemale = \\[(140 - age in years) × weight in kg × 0.85\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n\nMale = \\[(140 - age in years) × weight in kg × 1.00\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n\n\\*Unless the patient has documented Gilbert's syndrome. Patients with Gilbert syndrome may be eligible with total bilirubin up to 3 × ULN, provided direct bilirubin is within normal limits and per investigator discretion.\n\n\\*\\* Prior growth factors are allowed per treating investigator discretion (i.e. erythropoietin (EPO), Granulocyte-Macrophage Colony-Stimulating Factors (GM-CSF) such as Sargramostim, Platelet-Derived Growth Factor (PDGF), Granulocyte Colony-Stimulating Factors (G-CSF) including Filgrastim, Darbepoetin Alfa are allowed per standard of care. Refer to Section 4.2 for more information on supportive care measures.\n\nNote: All laboratory value permitted departures (described in the above table with a different ULN) should be clearly documented by the treating investigator in the sources.\n\nNote: Patients do not need to meet lab eligibility requirements after screening. For days of leukapheresis, refer to institutional guidelines for lab eligibility for leukaphereses (see Appendix F for Rube Walker Blood Center leukapheresis eligibility criteria).\n\nNote: The institutional upper limit refers to the reference range upper limit established by the institution where the laboratory tests were performed.\n\n\\- The effects of N-803 on the unborn fetus are unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from start of treatment, for the duration of study participation, and for 7 months following completion of N-803 therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 7 months after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n\n  * POCBP must have a negative pregnancy test during screening and per the study schedule. See Study Procedures in Section 5 for more information.\n  * Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements.\n\nExclusion Criteria\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per NCI CTCAE v 5.0 as deemed by the principal investigator.\n* Any medical diagnosis that would prevent the donation of WBCs or patients whom in the opinion of the investigator should not donate WBCs.\n* Patients with high risk of bleeding, as determined by treating investigator. Note: If patients are on anticoagulants, the investigator will determine if patient can continue anticoagulants throughout the study, or if their dosage needs to be changed until completion of both leukapheresis procedures.\n* Patients with illnesses or conditions that would prevent them from taking blood thinners or patients whom in the opinion of the investigator should not take blood thinners.\n* Patients who have received other IL-15 treatments since receiving TCR-T cells to the start of study treatment (C1D1).\n\nNote: Prior growth factors are allowed per treating investigator discretion (i.e. erythropoietin (EPO), Granulocyte-Macrophage Colony-Stimulating Factors (GM-CSF) such as Sargramostim, Platelet-Derived Growth Factor (PDGF), Granulocyte Colony-Stimulating Factors (G-CSF) including Filgrastim, Darbepoetin Alfa\n\n* Patients with new or progressing brain metastases. Note: Patients with treated brain metastases that are stable in the opinion of the treating investigator are eligible.\n* Known significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater, see Appendix C), myocardial infarction within 3 months prior to Pre-Dose Leukapheresis, unstable arrhythmias, or unstable angina. To be eligible for this trial, patients should be class 2B or better. See Appendix C for more information.\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to N-803 or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n* Participants who, in the opinion of the investigator, are unable to safely or feasibly receive subcutaneous injections of N-803. Examples include:\n\n  * Absence of suitable subcutaneous tissue for injection (e.g., due to cachexia, scarring, or anatomical limitations).\n  * Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to N-803, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n  * Active skin conditions or infections at potential injection sites.\n  * Physical or psychological inability to tolerate subcutaneous injection procedures (e.g., severe needle phobia, movement disorders).\n  * Medical contraindications to subcutaneous administration (e.g., bleeding disorders, severe dermatologic conditions).\n  * Any other factors that, in the judgment of the investigator, would interfere with safe and feasible administration of subcutaneous injections.\n* Major surgical procedure (as defined in Appendix E, e.g., GI surgery, removal or biopsy of brain metastasis), other than for diagnosis or known need for a major surgical procedure while on study treatment.\n\nNote: Patients must have fully recovered from complete wound healing from said surgery prior to first study assessment, in the opinion of the treating investigator.\n\nNote: Surgery and radiation are allowed after completion of Cycle 5 per discretion of treating investigator (CT scan and N-803 administration at Cycle 5 must have already occurred).\n\n* Systemic autoimmune disease currently requiring treatment (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The patient must have been off treatment for 90 days from registration.\n* History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (e.g., prednisone or hydrocortisone at doses of ≤ 10 mg\u002Fday of prednisone (or equivalent)) and corticosteroids used to manage AEs are permitted.\n\nPatients who require immunosuppressive agents during their study participation are ineligible, except:\n\n* Use of physiologic doses of systemic steroid replacement is permitted at doses of ≤ 10 mg\u002Fday of prednisone (or equivalent, e.g., dexamethasone 1.5 mg, methylprednisolone 8 mg, or hydrocortisone 40 mg).\n* Local steroids, including topical steroids (e.g., hydrocortisone, clobetasol), nasal steroids (e.g., fluticasone, mometasone), or inhaled steroids (e.g., budesonide, beclomethasone).\n* Limited courses (\\\u003C 1 week) of systemic steroids (≤ 10 mg\u002Fday of prednisone or equivalent) (e.g, in patients with exacerbations of reactive airway disease or anaphylaxis in patients who have known contrast allergies).\n* Immunosuppressive treatments to optimally manage immune-related AEs as clinically indicated\n\n  * Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the patient at high risk for treatment-related complications.\n  * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n    * Hypertension that is not controlled on medication\n    * Ongoing or active infection requiring systemic treatment including:\n* Known active infection with acute or chronic hepatitis B or C, known active human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome\n* Exception: uncomplicated urinary tract infections (or sinus infections and are on antibiotics)\n\n  * (AIDS)-related illness\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n\n    * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen except the following:\n* Basal cell carcinoma of the skin\n* Squamous cell carcinoma of the skin\n* In situ cervical cancer that has undergone potentially curative therapy - Patient is pregnant or nursing. Note: Pregnant patients are excluded from this study because N-803 is an interleukin-15 (IL-15) receptor agonist with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with N-803, breastfeeding should be discontinued if the mother is treated with N-803.\n\nNote: Serum test will be conducted at screening (serum pregnancy test (human chorionic gonadotropin \\[β-HCG\\]). See Study Procedures in Section 5 for more information.\n\n* Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* Patients who need to be on concurrent anticancer treatment (e.g., chemotherapy, immunotherapy, cytokine therapy \\[except erythropoietin\\]) throughout participation in the study.\n* Patients who have had prior use of narrow therapeutic index drugs that are substrates of major CYP450 enzymes within 14 days of first study drug administration per discretion of the treating investigator, including but not limited to:\n\n  * Tacrolimus\n  * Cyclosporine\n  * Sirolimus\n  * Everolimus\n  * Warfarin\n  * Phenytoin\n  * Midazolam\n  * Tamoxifen\n  * Codeine\n  * Erlotinib\n* Patients who have had prior use concomitant medications that prolong the QT\u002FQTc interval within 14 days of first study drug administration visit per discretion of the treating investigator.\n* Patients who have had prior biologic therapies or chemotherapy within 28 days of Pre-Dose Leukapheresis visit, or radiation therapy within 14 days of Pre-Dose Leukapheresis visit.\n\nPatient must have reviewed and signed the informed consent document before any study activities may occur. Registration of patients is completed in NOTIS. Please refer to Section 11.3 for details on the registration process.","18 Years","80 Years",{"count":69,"type":21},8,[71],"EARLY_PHASE1","This early phase I trial tests the safety and how well N-803 works in treating patients with synovial sarcoma (SS) or myxoid\u002Fround cell liposarcoma (MRCL) that is growing, spreading, or getting worse (progressive) after being treated with adoptive cellular therapy (ACT) using T-cell receptor therapy (T-CRT). Synovial sarcoma is a rare, slow-growing cancer that affects the soft tissues, like muscles or ligaments near the joints. Myxoid\u002Fround cell liposarcoma is a rare type of soft tissue sarcoma cancer that originates from fat cells usually in the arms and legs. N-803 is a type of immunotherapy-a treatment that helps patients' own immune system fight cancer, and it is made up of a natural protein called interleukin-15 (IL-15) that is important for growing and activating immune cells. Studies have shown that patients can progress after initially responding to TCR-T, so this trial will use N-803 to stimulate rare persisting cells (cells that survive treatment and cause treatment failure and disease relapse) to make them work better at attacking the cancer. Adoptive cell therapy is a type of therapy that uses a patient's own immune cells to fight cancer. T-cell receptor therapy is a type of ACT that can recognize better recognize and bind to protein in cancer cells. Giving N-803 may be safe and tolerable in patients with SS or MRCL.",[74,75,30],"Myxoid Liposarcoma","Round Cell Liposarcoma","2026-06-11",{"date":78,"type":50},"2026-06-15",{"date":80,"type":50},"2026-04-13",{"date":82,"type":21},"2032-09-02",{"name":84,"class":57},"Seth Pollack",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":58},"100509198","synovial-sarcoma-registry--biospecimen-repository-100509198","NCT05910307","Synovial Sarcoma Registry \u002F Biospecimen Repository","Synovial Sarcoma Registry and Biospecimen Repository","Inclusion Criteria:\n\n1. Males or females of any age\n2. Reported diagnosis of synovial sarcoma\n3. Informed consent from subject (aged ≥18 years) or parent\u002Fguardian\n\nExclusion Criteria:\n\n1. Individuals with sarcomas that do not fit the definition of those considered for this registry\n2. Individuals who are unwilling to participate\n3. Individuals who are unwilling or unable to provide written consent",{"count":93,"type":21},1000,"10 Years","OBSERVATIONAL","The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.\n\nParticipants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.",[30],[99,100,101,102,103,104],"registry","biorepository","sarcoma","oncology","cancer","rare tumor","2026-06-05",{"date":107,"type":50},"2026-06-09",{"date":109,"type":50},"2023-06-12",{"date":111,"type":21},"2033-06",{"name":113,"class":57},"Children's Hospital of Philadelphia",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100477109","phase-1-start-safety-and-anti-tumor-activity-of-pepticrad-1-in-treatment-of-cancer-100477109","NCT05492682","START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer","A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3","Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female, ≥18 years of age.\n3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to\u002Fafter standard therapy or the patient has refused or does not tolerate standard therapy:\n\n   * Inoperable\u002Fmetastatic cutaneous malignant melanoma\n   * Relapsed or newly diagnosed locally advanced inoperable\u002Fmetastatic TNBC\n   * Inoperable advanced\u002Fmetastatic non-squamous NSCLC\n   * Inoperable and\u002For advanced Synovial or myxoid round cell sarcoma\n   * Inoperable and\u002For advanced osteosarcoma\n   * Inoperable and\u002For advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n   * Inoperable and\u002For advanced\u002Fmetastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n5. Tumor lesion which is deemed feasible for biopsy and injection\n6. ECOG\u002FWHO performance status 0 to 1.\n7. Acceptable liver and renal function, defined as:\n\n   * Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and\n   * Serum creatinine ≤1.5 x ULN\n8. Acceptable hematological function, defined as:\n\n   * Hemoglobin ≥9 g\u002FdL, and\n   * Neutrophils ≥1.5 x 109\u002FL, and\n   * Platelet count ≥100 x 109\u002FL Patients may be transfused to meet the hemoglobin entry criteria.\n9. Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal.\n10. Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period.\n\n    Urine pregnancy tests should have a sensitivity of at least 25 mIU\u002FmL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood.\n11. Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment\n\nExclusion Criteria:\n\n1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.\n2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \\>10 mg\u002Fday prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.\n3. Prior or concomitant radiotherapy within 4 weeks before Day 1.\n4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.\n5. Active bacterial, viral, or fungal infection that requires systemic therapy.\n6. Active autoimmune disease that has required systemic treatment in the past two years.\n7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.\n8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.\n9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.\n10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.\n\n    Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.\n11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:\n\n    * Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1\n    * Grade 2 or higher pneumonitis\n    * Grade 4 AST or ALT elevation\n    * Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.\n12. History of or planned tissue \u002F organ transplant.\n13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.\n14. Unwillingness or inability to comply with the study protocol for any reason.\n15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities.\n16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and\u002For involved directly in the study.\n17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.",{"count":5,"type":21},[24],"This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.",[125,126,127,30,74,128,39,129],"Melanoma (Skin)","Triple-Negative Breast Cancer","Non-Small Cell Lung Cancer","Colorectal Cancer","Sarcoma","2026-05-11",{"date":132,"type":50},"2026-05-12",{"date":134,"type":50},"2023-02-02",{"date":136,"type":21},"2027-05-31",{"name":138,"class":139},"Valo Therapeutics Oy","INDUSTRY",7,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"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.","2 Years","40 Years",{"count":152,"type":21},30,[24,25],"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.",[40,29,30],[157,158,159],"metastasized fusion-driven sarcoma","clinical study","phase I\u002FII","2026-04-28",{"date":162,"type":50},"2026-05-04",{"date":164,"type":50},"2023-09-19",{"date":166,"type":21},"2027-09",{"name":168,"class":57},"University Hospital Tuebingen",4,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":67,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":58},"100522535","phase-1-phase-iib-study-of-nk-expressing-an-affinity-enhanced-t-cell-receptor-tcr-against-the-ny-eso-1-100522535","NCT06083883","Phase I\u002FIb Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1","Phase I\u002FIb Study of Adoptive NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Reactive Against the NY-ESO-1-specific Cord Blood-derived NK Cells (NY-ESO-1 TCR\u002FIL-15 NK) in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Synovial Sarcoma and Myxoid\u002FRound Cell Liposarcoma","Inclusion Criteria:\n\n1. Patients with all cancer histology, with an HLA-A\\*02:01, HLA-A\\*02:05 or HLA-A\\*02:06 positive and a positive expression of NY-ESO-1 (\\>\u002F= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the dose escalation cohort. NY-ESO expression must be confirmed at MDACC prior to study entry.\n2. Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid\u002Fround cell liposarcoma (cohort 2), with an HLA-A\\*02:01, HLA-A\\*02:05 or HLA-A\\*02:06 positive and a positive expression of NY-ESO-1 (\\>\u002F= 50% tumor cells 2+ or 3+ by IHC) in the pre-enrollment tumor sample, for the expansion cohorts. Archival samples will be permitted for screening. NY-ESO expression must be confirmed at MDACC prior to study entry.\n3. Patients must meet disease-specific eligibility criteria (see below).\n4. Patients must have relapsed or become refractory to standard of care treatment and must have received at least one prior line of systemic therapy including either doxorubicin and\u002For ifosfamide (synovial sarcoma and MRCLS) or trabectedin (MRCLS).\n5. Patients must have measurable disease per the RECIST v1.1 at enrollment.\n6. Patients must be at least 2 weeks from last cytotoxic chemotherapy at the time of first administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least 3 days prior to administration of lymphodepleting chemotherapy.\n7. Patients must be at least 3 months from any cell therapy for malignancy.\n8. Eastern Cooperative Oncology Group performance status 0-1 (Appendix A).\n9. 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) ≥45 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,\n   5. Hematological: absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, platelet count ≥ 75,000\u002Fmm3, and hemoglobin ≥ 8 g\u002FdL\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.\n10. Able to provide written informed consent.\n11. Aged 16-80 years.\n12. Weight ≥40 kg.\n13. 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.\n\n    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.\n14. 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.\n15. Signed consent to long-term follow-up on protocol PA17-0483.\n16. Disease-specific inclusion criteria\n17. Advanced solid tumors a. Patients with locally advanced and\u002For metastatic solid tumors may be enrolled in the dose escalation phase. Patients must have received at least one prior line of standard therapy.\n\n18 Synovial Sarcoma (SS)\n\na. Patients must have a histologically confirmed diagnosis of synovial sarcoma with a confirmation by the presence of a translocation between SYT on the X chromosome and SSX1, SSX2 or, SSX4 on chromosome 18 (may be presented in the pathology report as t (X; 18)).\n\n19\\. Myxoid\u002Fround cell liposarcoma (MRCLS)\n\na. Patients must have histologically confirmed myxoid\u002Fround cell liposarcoma with a confirmation by the presence of the reciprocal chromosomal translocation t(12;16)(q13;p11) or t(12; 22) (q13;q12).\n\nExclusion Criteria:\n\n1. Presence of clinically significant ≥ Grade 2 toxicity from previous anticancer treatment, as determined by the PI.\n2. 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.\n3. Known Active hepatitis B or C.\n4. Known human immunodeficiency virus with detectable viral load.\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).\n7. Amyloidosis or POEMS syndrome.\n8. Symptomatic or uncontrolled central nervous system involvement or signs of cord compression.\n\n   In the case radiation therapy is indicated, the washout must be at least 14 days.\n\n   Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using corticosteroids for at least 7 days prior to trial treatment.\n9. 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-lifethreatening 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.\n10. 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 NY-ESO-1 TCR\u002FIL-15 NK cell infusion\n    * Unstable angina within ≤ 13 weeks prior to NY-ESO-1 TCR\u002FIL-15 NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)\n    * Severe aortic stenosis.\n    * Uncontrolled arrhythmia, considered per PI evaluation.\n    * Congenital long QT syndrome.\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.\n11. Major surgery \\\u003C 4 weeks prior to first dose of lymphodepleting chemotherapy.\n12. Concomitant use of other investigational agents.\n13. Concomitant use of other anticancer agents.\n14. Previously received any anti-NY-ESO-1 therapy.\n15. 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).\n16. Received antithymocyte globulin within 14 days or Campath within 28 days of enrollment.\n17. Patients receiving immunosuppressive therapy.\n18. Patients who received live vaccines within 30 days prior enrollment.\n19. Pregnant or breastfeeding.","16 Years",{"count":179,"type":21},44,[24],"The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.",[30,183],"Myxoid\u002FRound Cell Liposarcoma",{"date":185,"type":50},"2026-04-16",{"date":187,"type":50},"2024-03-27",{"date":189,"type":21},"2028-11-30",{"name":191,"class":57},"M.D. Anderson Cancer Center",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100287066","phase-3-phase-iii-trial-of-anlotinib-catequentinib-in-advanced-alveolar-soft-part-sarcoma-leiomyosarcoma-synovial-sarcoma-apromiss-100287066","NCT03016819","Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma","APROMISS","Inclusion Criteria\n\n1. Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a written informed consent form.\n2. Male or female at least 18 years of age.\n3. a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone). c. CLOSED Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma. d. CLOSED Indication D - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).\n\n3\\. Open Indication E: Any sarcomas or other solid tumors 4. a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy. (New Recruitment Suspended) c. Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). d. Indication D - LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment. Patients must have received and progressed on prior therapy and have been treated any line with an anthracycline. e. Indication E: Any sarcomas or other solid tumors such as NSCLC, SCLC and Thyroid cancer etc.: Subjects exhausted SOC treatment or refuse for any SOC treatment.\n\n5\\. Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment (excluding ASPS subjects who have not received prior therapy).\n\n6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by CT or MRI scan of the chest, abdomen and pelvis (and other areas of disease) within 28 days prior to enrollment. 8. Life expectancy of at least 3 months.\n\n9\\. Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.\n\n10\\. Female of childbearing potential must be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation), abstinent (at the discretion of the investigator), or agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 2 years. Males must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) at the discretion of the investigator. 11. Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 28 days of enrollment:\n\na. Total bilirubin \\\u003C the upper limit of normal (ULN), unless the patient has documented Gilbert's disease for which the total bilirubin should be \\\u003C 3. b. Alanine aminotransferase and aspartate aminotransferase \\\u003C 2.5 of the ULN (\\\u003C 5 x of ULN for subjects with liver involvement of their cancer) c. Amylase and lipase \\\u003C 1.5 x of ULN d. Serum creatinine \\\u003C 1.5 x of ULN e. Glomerular filtration rate \\> 30ml\u002Fmin\u002F1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula or creatinine clearance (CrCL) \\> 60 ml\u002Fmin (Cockcroft and Gault) or by 24 hour urine collection. f. International normalize ratio (INR) and the activated partial thromboplastin time (aPTT\u002FPTT) \\\u003C 1.5 x ULN. (Subjects who are therapeutically treated with an agent such LMWH or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists) g. Platelet count \\> 100,000 cells\u002Fmm3, hemoglobin \\> 9 g\u002FdL, absolute neutrophil count \\> 1,500 cells\u002Fmm3 h. Alkaline phosphatase limit \\\u003C2.5 x ULN (\\\u003C5 x ULN for subjects with liver involvement of their cancer) i. Urine protein \\\u003C 30 mg\u002FdL. If urine protein is \\> 30 mg\u002FdL, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1,000 mg per 24 hours or spot urine protein (mg\u002FdL) to creatinine (mg\u002FdL) ratio must be \\\u003C1.0.\n\n12\\. Left ventricular ejection fraction (LVEF) of \\> 50% by ECHO or MUGA within 56 days of enrollment. 13. Two readings of systolic blood pressure \\\u003C 140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg at screening taken at least 5 minutes apart in the sitting position after 5 minutes of rest. Subjects with well managed hypertension who are on oral antihypertensives must be on their current medication(s) and stable dose(s) for at least 2 weeks prior to enrollment.\n\nExclusion Criteria\n\n1. Prior treatment with or have known hypersensitivity to AL3818.\n2. a. Indication A - ASPS: Prior treatment with cediranib. b. Indication B - LMS: Prior treatment with or have known hypersensitivity to dacarbazine. (New Recruitment Suspended) c. Indication C - SS: Prior treatment with or have known hypersensitivity to dacarbazine.\n\n   d. Indication D - LMS: Prior treatment with anlotinib.\n3. Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LMS, or SS within 5 years before enrollment except for successfully treated in situ carcinoma, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).\n4. Received last dose of systemic cytotoxic therapy or investigational therapy within 21 days of enrollment or last dose of hormonal therapy, immunotherapy, targeted therapy or any other type of non-cytotoxic anti-cancer therapy within 14 days of enrollment.\n5. Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.\n6. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided that they are stable with no evidence of progression by imaging, and all neurologic symptoms have returned to baseline, and should not be using corticosteroids for at least 7 days prior to study treatment.\n7. Cavitary tumors or tumors invading or abutting large blood vessels in the thorax.\n8. History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.\n9. Known history of bleeding disorders (e.g., von Willebrand disease or hemophilia).\n10. Clinically significant bleeding such as gross hematuria, gastrointestinal bleeding and hemoptysis within 6 months prior to enrollment.\n11. CTCAE version 4.03 \\> grade 2 pulmonary hemorrhage or \\> grade 3 of other forms of bleeding within 28 days prior to enrollment.\n12. History of untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin which is exclusionary) for at least 14 days prior to start of study treatment.\n13. Use of aspirin (\\>325 mg\u002Fday) within 10 days prior to the first dose of study treatment.\n\n    The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.\n14. Serious non-healing wound, active ulcer.\n15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment or minor surgical procedure within 7 days of enrollment.\n16. CTCAE version 4.03 \\> grade 3 peripheral neuropathy\n17. Any unrecovered toxicity reactions of CTCAE version 4.03 \\> grade 1 caused by any previous therapy (excluding alopecia and neurotoxicity \\\u003C grade 2)\n18. QTcF \\> 470 msec (per Fridericia's formula) on electrocardiogram within 28 days of enrollment.\n19. Severe and uncontrolled disease, including:\n\n    1. Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure classified according to New York Heart Association (NYHA)\n    2. Active or failed to control serious infections (CTCAE version 4.03 \\> grade 2 infections)\n    3. Liver disease such as cirrhosis of the liver, decompensated liver disease, chronic active hepatitis needing anti-viral therapy\n    4. Renal failure needing hemodialysis or peritoneal dialysis\n    5. Poorly controlled diabetes (HgA1C \\>8)\n    6. Untreated and uncontrolled epileptic seizures\n    7. History of psychotropic drug abuse and inability to quit\n    8. Untreated psychiatric disorders\n20. Known HIV-positive\n21. Had organ transplantation\n22. Clinical conditions affecting the intake and use of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)\n23. Females who are pregnant or are breast-feeding.\n24. Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5; or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19; or QT prolongating medications within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.\n25. Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.",{"count":201,"type":21},325,[203],"PHASE3","THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA.\n\nThis study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.",[33,206,30,207],"Leiomyosarcoma","Soft-Tissue Sarcoma","2026-02-23",{"date":210,"type":50},"2026-02-25",{"date":212,"type":50},"2017-08-15",{"date":214,"type":21},"2028-12",{"name":216,"class":139},"Advenchen Laboratories, LLC",24,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":232,"locationsCount":234},"100563546","expanded-access-protocol-eap-for-nonconforming-nc-afami-cel-100563546","NCT06617572","Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel","Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification","Inclusion Criteria:\n\n* Patient must provide written informed consent prior to participating in this protocol\n* Patient must have been prescribed TECELRA®\n* Patient's commercially manufactured product does not meet the commercial release specification\n* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with Adaptimmune\n* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment\n* The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient\n* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment\n* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy\n\nExclusion Criteria:\n\n* Patient has contraindication(s) as per the TECELRA® USPI\n* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\\*02:05P","EXPANDED_ACCESS","The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.",[30,74],"AVAILABLE","2026-02-05",{"date":231,"type":50},"2026-02-09",{"name":233,"class":139},"USWM CT, LLC",11,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":149,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100488618","phase-1-spearhead-3-pediatric-study-100488618","NCT05642455","SPEARHEAD-3 Pediatric Study","A Phase 1\u002F2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors","Inclusion Criteria:\n\n* Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).\n* Age:\n\n(A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years\n\n* Body weight ≥ 10 kg\n* Must have previously received a systemic chemotherapy\n* Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).\n* HLA-A\\*02 positive\n* Tumor shows MAGE-A4 expression confirmed by central laboratory.\n* Performance Status:\n\n(A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80\n\n• Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Positive for HLA-A\\*02:05 in either allele; or any A\\*02 having same protein sequence as HLA-A\\*02:05\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.\n* History of autoimmune or immune mediated disease\n* Known central nervous system (CNS) metastases.\n* Other prior malignancy that is not considered by the Investigator to be in complete remission\n* Clinically significant cardiovascular disease\n* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus\n* Pregnant or breastfeeding\n* Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.","21 Years",{"count":244,"type":21},20,[24,25],"This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\\*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.",[30,248,249,39],"Malignant Peripheral Nerve Sheath Tumor (MPNST)","Neuroblastoma (NBL)",{"date":231,"type":50},{"date":252,"type":50},"2023-09-01",{"date":254,"type":21},"2038-07-30",{"name":233,"class":139},10,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":264,"maxAge":18,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":273,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":58},"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","1 Year",{"count":266,"type":21},25,[24],"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.",[129,270,39,29,40,30,271,272],"HER-2 Protein Overexpression","Soft Tissue Sarcoma","Undifferentiated Sarcoma",[129,274,275,276,277,39,29,278,279,280,281],"Her-2 Positive Sarcoma","autologous T cells","HER2 positive recurrent or progressive sarcoma","HER2 CAR T cells","Ewing sarcoma","Synovial sarcoma","Soft tissue sarcoma","Undifferentiated sarcoma","2026-01-21",{"date":284,"type":50},"2026-01-22",{"date":286,"type":50},"2021-12-07",{"date":288,"type":21},"2043-06-30",{"name":290,"class":57},"Baylor College of Medicine",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":169},"100588809","phase-1-actengine-ima203-combined-with-mrna-4203-100588809","NCT06946225","ACTengine® IMA203 Combined With mRNA-4203","A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)","Inclusion Criteria:\n\n* Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease\n* HLA-A\\*02:01 positive\n* Adequate selected organ function per protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n* Life expectancy more than 5 months\n* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor\n* SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.\n* Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration\n\nOther protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease\n* History of cardiac conditions as per protocol\n* Prior allogenic stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2\n* History of hypersensitivity to mRNA-based medicines\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection\n* Any condition contraindicating leukapheresis\n* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol\n* Participants with active brain metastases prior to lymphodepletion\n* Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment\n* Participants with renal impairment AND reduced bone marrow reserve per protocol\n\nOther protocol defined exclusion criteria could apply",{"count":5,"type":21},[24],"This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).",[302,30],"Cutaneous Melanoma",[304,305,306,307,308,309,310],"immunotherapy","T-cell therapy","cutaneous melanoma","synovial sarcoma","RNA vaccine","Immatics","Moderna","2026-01-06",{"date":313,"type":50},"2026-01-08",{"date":315,"type":50},"2025-07-25",{"date":317,"type":21},"2029-08",{"name":319,"class":139},"Immatics US, Inc.",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":58},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":329,"type":21},148,[25],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[206,333,30,334,335,37,336,337,338,339,34],"Liposarcoma","Angiosarcoma","Undifferentiated Pleomorphic Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","2025-07-20",{"date":342,"type":50},"2025-07-24",{"date":344,"type":50},"2024-02-21",{"date":346,"type":21},"2027-02",{"name":348,"class":139},"HRYZ Biotech Co.",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":357,"maxAge":358,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":169},"100551151","phase-2-pasireotide-as-maintenance-treatment-in-synovial-sarcoma-and-desmoplastic-small-round-cell-tumor-100551151","NCT06456359","Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor","Pasireotide as Maintenance Treatment With Monthly Deep Intramuscular Injection in SSTR2\u002F3\u002F5-Expressing Synovial Sarcoma and Desmoplastic Small Round Cell Tumor","PAMSARC","Inclusion Criteria:\n\nPatients meeting all of the following criteria are considered for enrolment into the trial:\n\n1. Reference pathological proven diagnosis of DSRCT in any stage; or Reference pathological proven diagnosis of SySa, IRS III, metastatic or relapsed disease\n2. High SSTR2\u002F3\u002F5 mRNA expression, as determined by RNA sequencing in the DKFZ\u002FNCT\u002FDKTK MASTER (ClinicalTrials.gov ID: NCT05852522) or INFORM programs.\n3. Stable disease, partial or complete response after completion of standard treatment\n4. Age from 13 to 50 years\n5. For patients (≥16 years): Karnofsky-Index ≥ 80% For patients (\\\u003C16 years): Lansky-Index ≥ 80%\n6. No curative treatment option\n7. Bodyweight ≥ 30kg and BSA ≥ 1.1m²\n8. Time from last chemotherapy (at least 2 chemotherapy cycles) to enrollment \\\u003C8 weeks\n9. Ability of patient to understand character and individual consequences of the clinical trial\n10. Written informed consent (for individuals \\\u003C18 years of age an ICF for adolescents and their parents is needed)\n11. For women of childbearing potential negative urine pregnancy test at screening as well as highly effective forms of contraception have to be in place thereafter\n\n    * Evidence of childbearing potential is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile\n    * Postmenopausal or evidence of non-childbearing status is defined as:\n\n      * Amenorrhea for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments plus follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using hormonal contraception or hormonal replacement therapy.\n      * Chemotherapy-induced menopause\n      * Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, total hysterectomy or tubal ligation at least 6 weeks before IMP treatment)\n    * A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n12. Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly effective method). These should be started immediately after signing the informed consent form and continued throughout the period of study treatment plus 3 months for female and male patients . Male patients should refrain from fathering a child or donating sperm during the trial and for at least 3 months following the last dose.\n13. Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:\n\n    * Hemoglobin ≥ 10 g\u002Fdl\n    * Neutrophil count ≥ 1,500\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fµl\n    * Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n    * ALT and AST ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n    * PT-INR\u002FPTT ≤ 1.5 x ULN\n    * Albumin ≥ 25 g\u002Fl\n    * Creatine kinase ≤ 2.5 x ULN\n    * Serum creatinine \\\u003C or = 1.5 mg\u002Fdl or creatinine clearance = or \\> 51 ml\u002Fmin (calculation according to Crockroft-Gault)\n\nExclusion Criteria:\n\nPatients presenting with any of the following criteria are not included in the trial:\n\n1. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product\n2. Concurrent or previous treatment within 30 days in another interventional clinical trial \u002F Participation in other ongoing clinical trials.\n3. Uncontrolled concurrent disease, in particular diabetes mellitus\n4. Bleeding disorder\n5. Therapeutic anticoagulation which cannot be paused temporarily in order to ensure safe intramuscular injection\n6. Is taking or requiring any of the prohibited medication listed in Table 5 (6.4.2)\n7. Heart rate at rest \\\u003C 60\u002Fmin\n8. fasting glucose level \\> 110mg\u002Fdl\n9. Severe neurologic or psychiatric disorder\n10. Pregnancy\u002Flactation\n11. Prior treatment with somatostatin analog\n\n    \\-","13 Years","50 Years",{"count":360,"type":21},28,[25],"PAMSARC is a non-commercial interventional Phase 2 clinical trial of academic research institutions, with its primary goal being to improve medical treatment of fusion driven Desmoplastic small round cell tumor (DSRCT) and Synovial sarcoma (SySa) in young adults and adolsecents with male predominance.\n\nCurrent management of DSRCT and SySa includes chemotherapy, radiation and aggressive cytoreductive surgery. Despite advances in multimodal therapy, outcomes remain poor with frequent disease recurrence and very limited options for patients with advanced disease.\n\nSelected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, are frequently overexpressed in DSRCT and SySa, providing the rationale for treatment with somatostatin analogues (SSA).\n\nPasireotide is a SSA with high affinity for SSTR1, -2, -3, and -5 and is approved for the treatment of Cushing's disease and acromegaly and has also shown activity in other cancers. In patients with advanced stage DSRCT and SySa, conventional chemotherapeutic approaches frequently lead to disease response, however, the duration of progression-free time after chemotherapy is short. The targeted approach with pasireotide after initial intensive multimodal treatment may have the potential to significantly improve outcome.",[34,30],[365,366,367,368,369,370,371,372,373,374],"SSTR","somatostatin receptor","SSTR2, SSTR3, SSTR5","somatostatin analog","pasireotide","fusion-gene driven","SS18-SSX1, SS18-SSX2, SS18-SSX4","EWSR1-WT1","extremely rare, aggressive sarcoma","maintaince therapy","2025-01-09",{"date":377,"type":50},"2025-01-13",{"date":379,"type":50},"2024-12-19",{"date":381,"type":21},"2028-10",{"name":383,"class":57},"University Hospital Heidelberg",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":22,"phases":394,"briefSummary":395,"conditions":396,"keywords":400,"overallStatus":417,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":58},"100573637","phase-1-epitome-1015-i-a-study-to-investigate-the-safety-and-tolerability-of-mdg1015-in-patients-with-epithelial-ovarian-cancer-gastroesophageal-adenocarcinoma-round-cell-liposarcoma-andor-synovial-sarcoma-100573637","NCT06748872","EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer, Gastroesophageal Adenocarcinoma, Round Cell Liposarcoma And\u002For Synovial Sarcoma","EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And\u002For Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And\u002For LAGE-1a","EPITOME-1015-I","Inclusion Criteria:\n\n1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4\n2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma\n3. Subject's must have tested positive for HLA-A\\*02:01 genotype by a Sponsor designated central laboratory\n4. Subject's tumor must have tested positive for NY-ESO-1 and\u002For LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed\n5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit\n6. Subjects must have\n\n   1. measurable disease\n   2. Life expectancy ≥ 3 months per Investigator's opinion\n\n8\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior\u002Fongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)\n\nExclusion Criteria:\n\n1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined\n2. HLA-A\\*02:02 or HLA-A\\*02:03 genotype\n3. Pregnant or lactating women\n4. Viral serology:\n\n   1. Known infection with HIV-1\u002F2, CMV (CMV required only for U.S. sites) or HTLV-1\u002F2,\n   2. Active infection with HBV or HCV\n   3. Positive test for Mycoplasma or Treponema Pallidum\n5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)\n6. Inadequate venous access for or contraindications to leukapheresis\n7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.\n8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease\n9. Unstable\u002Factive ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding\n10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:\n\n    1. non-melanoma skin cancer\n    2. curatively treated localized prostate cancer\n    3. carcinoma in situ (e.g. cervix, bladder, breast)\n11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (\\> 30 seconds) ventricular tachyarrhythmias\n12. Subjects who are dependent on dialysis\n13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator\n14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease\n15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant\n\n    Specific to GAC\u002FGEJ Subjects:\n16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation",{"count":393,"type":21},55,[24],"MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1\u002FLAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and\u002For synovial sarcoma that expresses NY-ESO-1 and\u002For LAGE-1a.\n\nThe main questions this clinical trial aims to answer are:\n\nCan this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015?\n\nParticipants will:\n\nReceive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and\u002For potential disease response will be documented during this period.",[397,398,399,74,30],"Epithelial Ovarian Cancer","Gastro-esophageal Junction Cancer","Soft Tissue Sarcoma (STS)",[401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416],"TCR-T Therapy","dose escalation","Third Generation TCR-T Therapy","autologous, patient derived CD8+ T cells","single arm","open label","phase I","BOIN design","NY-ESO-1","LAGE-1a","solid tumors","PD1-41BB","Costimulatory Switch Protein","Armoring","Enhancement","First-in-human","NOT_YET_RECRUITING","2024-12-23",{"date":420,"type":50},"2024-12-27",{"date":422,"type":21},"2025-07-01",{"date":424,"type":21},"2042-08-01",{"name":426,"class":139},"Medigene AG",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":264,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":417,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients 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* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","85 Years",{"count":436,"type":21},1582,[438],"NA","This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[441,442,443,33,334,444,445,446,447,337,448,206,449,450,451,452,129,271,453,454,455,30,335],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Myxofibrosarcoma","Pleomorphic Liposarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Soft Tissue Sarcoma of the Trunk and Extremities","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","2024-07-24",{"date":458,"type":50},"2024-07-30",{"date":460,"type":21},"2025-01-28",{"date":462,"type":21},"2032-11-01",{"name":464,"class":465},"ECOG-ACRIN Cancer Research Group","NETWORK"]