Actively Recruiting
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
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2026-05-15
9
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, maximum tolerated dose, and feasibility of a new treatment called LauT-1, which involves modified T cells that target the cancer protein NY-ESO-1. This protein is found in some sarcoma and melanoma tumors but not in normal tissues. The study focuses on patients with advanced melanoma or sarcoma who have the right genetic markers (HLA-A*0201 or HLA-A*0205) and tumors expressing NY-ESO-1. The treatment involves collecting patients' own T cells, genetically modifying them to express a high-affinity receptor targeting NY-ESO-1, and expanding these cells to create LauT-1. Before infusion, patients receive non-myeloablative lymphodepleting chemotherapy with fludarabine and cyclophosphamide, plus low-dose tumor irradiation. The LauT-1 cells are then infused intravenously. The study uses a dose-escalation design with three cohorts to assess safety and dosing. Participants undergo screening and registration, tumor biopsies, leukapheresis to collect T cells, and treatment with chemotherapy, irradiation, and LauT-1 infusions. Patients are monitored closely for adverse effects during a treatment-limiting toxicity period and followed regularly with clinical exams, lab tests, and tumor assessments. Safety, treatment feasibility, and tumor response are measured up to 24 months after treatment to evaluate long-term outcomes.
CONDITIONS
Brief Title
NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.
- Patients with sarcoma who have received at least one line of standard therapy and failed to respond, progressed, or were intolerant.
- Patients with metastatic melanoma without BRAF mutation who have received at least one line of standard therapy and failed to respond, progressed, or were intolerant.
- Patients with metastatic melanoma with BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed, or were intolerant.
- Immunohistochemically documented NY-ESO-1 expression in at least 50% of tumor tissue and HLA-A0201 and/or HLA-A0205 positive.
- Age 18 years or older.
- Able to undergo leukapheresis.
- At least one lesion accessible to biopsy for translational research at Day 30.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy greater than 12 weeks.
- Radiologically measurable disease as per RECIST v1.1.
- Adequate organ function.
You will not qualify if you...
- Active second malignancy.
- Symptomatic or untreated brain metastases, including leptomeningeal carcinomatosis.
- History of idiopathic pulmonary fibrosis or active pneumonitis.
- Recent myocardial infarction or unstable angina within six months prior to enrollment.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Active severe systemic infections within 2 weeks prior to leukapheresis.
- Requirement for regular systemic immunosuppressive therapy.
- History of severe immediate hypersensitivity to any study agents or excipients.
- Pregnant or breastfeeding women.
- Concerns about reliable compliance with contraception requirements.
- Any serious underlying medical condition that could interfere with study medication or potential adverse events.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks depending on cohort and production time
Participants undergo leukapheresis to collect T cells, which are then genetically modified to produce the LauT-1 T cell product.
1 visit for leukapheresis; additional visits may occur during product manufacturing
Duration - 4 to 6 days
Participants receive non-myeloablative lymphodepleting chemotherapy and a single low-dose irradiation to prepare for T cell infusion.
Daily visits for chemotherapy over 4 to 6 days; 1 visit for irradiation
Duration - Up to 45 days after first infusion, possibly extended by 6 days depending on dosing schedule
Participants receive infusion of the LauT-1 T cells, followed by supportive care and monitoring during the treatment-limiting toxicity period.
1 infusion visit; weekly outpatient visits for up to 7 weeks during toxicity monitoring
Duration - Up to 24 months
Participants are followed with clinical and laboratory examinations and tumor assessments to monitor safety and treatment response.
Regular outpatient visits according to study schedule
Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Not Yet Recruiting
2
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
B
Bernhard Gentner, MD
V
Virginie Zimmer, Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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