[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584471":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":33,"locations":43,"responsibleParty":73,"collaborators":10,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":10,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Single arm study",null,[12,13,14],"Biological: NY-ESO-1 TCR redirected autologous T cell product","Radiation: Low-dose irradiation","Drug: Non-myeloablative lymphodepleting chemotherapy",[16,23,28],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","NY-ESO-1 TCR redirected autologous T cell product","Ex vivo expanded autologous CD4+\u002FCD8+ cells expressing the transgenic TCR I53F recognizing NY-ESO-1 peptides presented on tumor cells in the context of HLA-A\\*02.\n\nCohort 1: The LauT-1-ACT infusion contains a minimum of 3x10\\^8 transduced cells (i.e. CD3+vβ13.1+) and a maximum of 1x10\\^10 total cells.\n\nCohort 2 : Patients will receive a fixed dose of 3x10\\^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations.\n\nCohort 3: Patients will receive a fixed dose of 6x10\\^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations.",[9],[22],"LauT-1",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"RADIATION","Low-dose irradiation","1Gy will be administered using tomotherapy (Accuray) to all irradiable lesions, to all cohorts before the (first) LauT-1 infusion.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"DRUG","Non-myeloablative lymphodepleting chemotherapy","Cohort 1: Fludarabine (30 mg\u002Fm2 per day, from D-6 to D-3) and cyclophosphamide (2400 mg\u002F m2 x 2 days, on days -6 and -5) are administered as an IV infusion. The cyclophosphamide dose may be reduced to 1800mg\u002Fm2 on days -6 and -5, if the patient has previously been exposed to significant cumulative doses of chemotherapy).\n\nCohorts 2 and 3: Fludarabine (30 mg\u002Fm2 per day, from D-6 to D-3) and cyclophosphamide (900 mg\u002F m2 x 2 days, on days -6 and -5) are administered as an IV infusion.",[9],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Bernhard Gentner, MD","CONTACT","+4179 556 90 20","Bernhard.Gentner@chuv.ch",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Virginie Zimmer, Study Coordinator","+41 21 314 97 09","virginie.zimmer@chuv.ch",[44,61],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Centre Hospitalier Universitaire Vaudois (CHUV)","NOT_YET_RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":53,"coordinates":54},"Point",[55,56],6.63282,46.516,{"lat":56,"lon":55},[59],{"name":35,"role":36,"phone":60,"phoneExt":10,"email":38},"+41 79 556 90 20",{"facility":5,"status":62,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"RECRUITING",{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67,69,71],{"name":35,"role":36,"phone":60,"phoneExt":10,"email":68},"bernhard.gentner@chuv.ch",{"name":40,"role":36,"phone":70,"phoneExt":10,"email":42},"+41795566947",{"name":35,"role":72,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":72,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Bernhard Gentner","Professor of Immuno-Oncology","100584471","phase-1-ny-eso-1-redirected-t-cells-in-patients-with-advanced-melanoma-and-sarcoma-100584471",false,"NCT06889766","NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma","A Phase I Study Evaluating Safety and Feasibility of Redirected Autologous T Cells Expressing a High Affinity TCR Specific for NY-ESO-1 (LauT-1) in Patients With Advanced Melanoma and Sarcoma","LauT1","Inclusion criteria at pre-screening\n\n1\\) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.\n\nInclusion criteria at screening\n\n1. Patients with sarcoma, who have received at least one line of standard therapy (if available) and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n2. Patients with metastatic melanoma:\n\n   1. Without proto-oncogene B-Raf (BRAF) mutation who have received at least one line of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n   2. With BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.\n3. Patient must have immunohistochemically documented NY-ESO-1 expression, defined as ≥ 1+ expression on either archival or fresh tumor tissue by immunohistochemistry, in ≥50% of the sampled tumor tissue AND HLA-A\\*0201 and\u002For HLA-A\\*0205 positive, as identified by high-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.\n4. Age ≥ 18 years\n5. Able to undergo apheresis\n6. At least one lesion accessible to biopsy for translational research (TR) at D30, without putting the patient at unusual risk.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n8. Life expectancy of greater than 12 weeks.\n9. Radiologically measurable disease (as per RECIST v1.1).\n10. Adequate organ function\n\nExclusion Criteria:\n\n1. Patients with an active second malignancy\n2. Patients with symptomatic and\u002For untreated brain metastases, as well as leptomeningeal carcinomatosis. Patients with definitively treated brain metastases will be considered for enrolment after agreement with the Principal Investigator, as long as lesions are stable, there are no new brain lesions, and the patient does not require chronic corticosteroid treatment.\n3. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin). History of radiation pneumonitis in the radiation field (fibrosis) is allowed.\n4. History of recent myocardial infarction, or unstable angina, within six months prior to enrolment\n5. Patients with prior allogeneic stem cell transplantation or organ transplantation\n6. Active severe systemic infections within 2 weeks prior to apheresis\n7. Patient requiring regular systemic immunosuppressive therapy. All immunosuppressive medications including but not limited to steroids, mycophenolate mofetil, azathioprine, methotrexate, thalidomide, and anti-Tumor Necrosis Factor-alpha (TNF-alpha) agents must have been discontinued at least 2 weeks before apheresis .\n8. History of severe immediate hypersensitivity reaction to any of the agents\u002F excipients of the study products.\n9. Women who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n10. Subjects, for whom there are concerns that they will not reliably comply with the requirements for contraception, should not be enrolled into the study.\n11. Any serious underlying medical condition that could interfere with study medication and potential adverse events.","ALL","18 Years",{"count":87,"type":88},9,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","A single center, dose escalaion, Phase I clinical trial to demonstrate safety and efficacy of LauT-1, autologous \"New York Esophageal Squamous Cell Carcinoma-1 T-Cell Receptor (NY-ESO-1 TCR)-directed T cells in combination with non-myeloablative (NMA) lymphodepleting chemotherapy and low dose irradiation (LDI) in patients with NY-ESO-1 positive sarcoma and melanoma.",[94,95,96],"Advanced Melanoma","Melanoma Metastatic","Sarcoma",[98,22,99,100,96,101],"NY-ESO-1","TCR redirected T cell","metastatic melanoma","autolog T-cell","2026-05-12",{"date":104,"type":105},"2026-05-15","ACTUAL",{"date":107,"type":105},"2025-03-24",{"date":109,"type":88},"2029-06",{"name":5,"class":6},2]