[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myxoid-liposarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myxoid-liposarcoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,77,105,122,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100613059","early-phase-1-n-803-in-patients-with-progressive-synovial-sarcoma-and-myxoidround-cell-liposarcoma-previously-treated-with-adoptive-cellular-therapy-100613059",false,"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.","ALL","18 Years","80 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Myxoid Liposarcoma","Round Cell Liposarcoma","Synovial Sarcoma","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":34},"2026-04-13",{"date":38,"type":21},"2032-09-02",{"name":40,"class":41},"Seth Pollack","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100580950","phase-1-a-study-of-mirdametinib-in-combination-with-palbociclib-in-people-with-liposarcoma-100580950","NCT06843967","A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma","A Phase Ib\u002FII Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma","Inclusion Criteria:\n\nPhase I only:\n\n* A diagnosis of unresectable, recurrent, or metastatic DDLPS\n* Measurable disease as defined by RECIST 1.1\n\nPhase II only:\n\n* A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS\n* Any number of prior lines of therapy\n\n  * Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration)\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n* Absolute neutrophil count ≥ 1.5 x 109\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Platelets ≥ 100 x 109\u002FL\n* Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN, except patients with Gilbert's disease (≤3x ULN)\n* AST (SGOT) \u002FALT (SGPT) ≤ 1.5 x institutional ULN\n* Creatinine Clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n\n  * Adequate coagulation function, as determined by:\n* International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \\> 1.5 × ULN is permitted but the dose must be stable for at least 2 weeks before the start of the study treatments.\n* PTT ≤ 1.5 × ULN.\n\n  * Adequate cardiac function, as determined by:\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg (Grade ≤ 2).\n* LVEF ≥ 50% by MUGA or ECHO.\n* No clinically significant ECG waveform abnormalities assessments at screening.\n\n  * Adequate glycemic control, as determined by:\n* Fasting blood glucose level \\\u003C 125 mg\u002FdL, or\n* Random blood glucose level \\\u003C 200 mg\u002FdL.\n\n  * Have normal serum calcium and phosphate levels (calcium level may be corrected for albumin level).\n  * Have intraocular pressure ≤ 21 mmHg in both eyes\n  * Women of child-bearing potential must agree to use highly effective contraceptive methods (hormonal or barrier method of birth control or abstinence) during the trial period through at least six months after the last dose. Male patients or their partners must be surgically sterile or agree to use adequate contraception while receiving trial treatment and for three months thereafter. Acceptable methods of contraceptive use by men or women are detailed in Section 15.3.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Ability to swallow tablets or capsules\n  * Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible.\n\nExclusion Criteria:\n\n* Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline.\n* Patients receiving any other investigational agents.\n* Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor\n* Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy.\n\n  * Patients with a CD4+ count of \\> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion.\n  * Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded.\n  * Patients with history of clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, clinically significant transient ischemic attack, symptomatic pulmonary embolism, unexplained syncope, or long QT syndrome within 6 months before the start of study treatment will be excluded.\n* Pregnant women and women who are breast-feeding.\n* Prolonged QTcF \\> 470ms at Screening, irrespective of sex.\n\n  o If a single 12-lead electrocardiogram (ECG) or, for patients with prolonged QT intervals or other cardiac indications, a triplicate ECG should be performed.\n* Current Chronic Kidney Disease stage \\> 3 or Creatinine Clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n* Current or history of Interstitial Lung Disease\n* History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any ophthalmological finding that could be a significant risk factor for RVO, retinopathy or neovascular macular degeneration.\n* Concurrent neuromuscular disorder that is associated with the potential of elevated CPK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* Radiation therapy within 2 weeks prior to study Day 1\n* Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.\n* Patient is receiving systemic (oral or IV\u002FSC) or ocular glucocorticoid therapy (with the exception of participants with endocrine deficiencies who are allowed to receive physiologic or stress doses of steroids, if necessary) within 14 days prior to first dose of study treatment\n* Known prior severe hypersensitivity to investigational product or any component in its formulation.\n\n  o This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Subjects with hypersensitivity to these agents will be excluded from enrollment.\n* History of significant toxicity related to prior CDK4\u002F6, MEK, or ERK inhibitor requiring discontinuation of treatments with these agents.\n* Concurrent, clinically significant, active malignancies within 12 months of study enrollment\n* Current evidence of a disorder that could reduce the ability to swallow oral dosage forms or alter absorption of orally administered drugs.\n* Patients who require concomitant use of medications that strongly induce or inhibit CYP3A or UDP-glucuronosyltransferase (UGT)\n* Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. Non-tolerable Grade 2 toxicities are defined as those with moderate symptoms that the subject is not able to endure for the conduct of instrumental activities of daily life or that persists ≥ 7 days.",{"count":51,"type":21},54,[53,54],"PHASE1","PHASE2","The purpose of this study is to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.",[57,58,59,27,28,60,61,62,63],"Well Differentiated Liposarcoma","Dedifferentiated Liposarcoma","Liposarcoma","Myxoid Pleomorphic Liposarcoma","Pleomorphic Liposarcoma","Unresectable Liposarcoma","Unresectable Dedifferentiated Liposarcoma",[57,58,59,27,28,60,61,62,63,65,66,67],"Unresectable Well Differentiated Liposarcoma","24-344","Memorial Sloan Kettering Cancer Center","2026-05-20",{"date":70,"type":34},"2026-05-22",{"date":72,"type":34},"2025-02-19",{"date":74,"type":21},"2028-08-19",{"name":67,"class":41},7,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"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":85,"type":21},15,[53],"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.",[89,90,91,29,27,92,93,94],"Melanoma (Skin)","Triple-Negative Breast Cancer","Non-Small Cell Lung Cancer","Colorectal Cancer","Osteosarcoma","Sarcoma","2026-05-11",{"date":97,"type":34},"2026-05-12",{"date":99,"type":34},"2023-02-02",{"date":101,"type":21},"2027-05-31",{"name":103,"class":104},"Valo Therapeutics Oy","INDUSTRY",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":119,"locationsCount":121},"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.",[29,27],"AVAILABLE","2026-02-05",{"date":118,"type":34},"2026-02-09",{"name":120,"class":104},"USWM CT, LLC",11,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":42},"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":131,"type":21},55,[53],"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.",[135,136,137,27,29],"Epithelial Ovarian Cancer","Gastro-esophageal Junction Cancer","Soft Tissue Sarcoma (STS)",[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154],"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":158,"type":34},"2024-12-27",{"date":160,"type":21},"2025-07-01",{"date":162,"type":21},"2042-08-01",{"name":164,"class":104},"Medigene AG",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":174,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":42},"100416179","international-prospective-registry-on-local-treatment-approaches-in-mls-100416179","NCT04699292","International Prospective Registry on Local Treatment Approaches in MLS","International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas","Inclusion Criteria:\n\n* Age \\> 18 years\n* Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)\n* ECOG PS 0-2\n* Written informed consent to share coded information in this international Registry\n\nExclusion Criteria:\n\n* Prior radiotherapy to the target area\n* Pregnancy",{"count":173,"type":21},300,"5 Years","OBSERVATIONAL","To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)",[27],"2022-08-29",{"date":180,"type":34},"2022-08-30",{"date":182,"type":34},"2021-01-18",{"date":184,"type":21},"2031-01",{"name":186,"class":41},"The Netherlands Cancer Institute"]