Actively Recruiting
NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2025-04-20
9
Participants Needed
2
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single center, 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.
CONDITIONS
Official 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
- NY-ESO-1 protein expression of at least 1+ in 50% or more of tumor cells by immunohistochemistry
- Sarcoma patients must have failed, progressed, or been intolerant to at least one line of standard therapy, or have documented reason for ineligibility or refusal
- Metastatic melanoma patients without BRAF mutation must have failed, progressed, or been intolerant to at least one line of standard therapy, or have documented reason for ineligibility or refusal
- Metastatic melanoma patients with BRAF mutation must have failed, progressed, or been intolerant to at least two lines of standard therapy, or have documented reason for ineligibility or refusal
- Positive for HLA-A0201 and/or HLA-A0205 by high-resolution DNA typing
- Age 18 years or older
- Able to undergo leukapheresis
- At least one lesion accessible for biopsy at day 30 without unusual risk
- Eastern Cooperative Oncology Group (ECOG) performance status 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 or leptomeningeal carcinomatosis; stable treated brain metastases allowed with PI agreement and no need for chronic corticosteroids
- History of idiopathic pulmonary fibrosis or active pneumonitis; radiation pneumonitis fibrosis allowed
- History of recent myocardial infarction or unstable angina within 6 months prior to enrollment
- Prior allogeneic stem cell or organ transplantation
- Active severe systemic infections within 2 weeks prior to leukapheresis
- Need for regular systemic immunosuppressive therapy within 2 weeks prior to leukapheresis
- History of severe immediate hypersensitivity to any study product agents or excipients
- Pregnancy or breastfeeding
- Concerns about reliable contraception compliance
- Any serious underlying medical condition that could interfere with study medication or adverse event management
AI-Screening
AI-Powered Screening
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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
CONTACT
V
Virginie Zimmer, Study Coordinator
CONTACT
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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