NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma

Recruiting now · Phase 1

Conditions studied: Advanced Melanoma, Melanoma Metastatic, Sarcoma

In brief

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.

Key facts

Study ID

NCT06889766

Run by

Centre Hospitalier Universitaire Vaudois

People needed

9

Starts

2025-03-24

Expected to finish

2029-06-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with an active second malignancy
• Patients with symptomatic and/or 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.
• History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin). History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
• History of recent myocardial infarction, or unstable angina, within six months prior to enrolment
• Patients with prior allogeneic stem cell transplantation or organ transplantation
• Active severe systemic infections within 2 weeks prior to apheresis
• 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 .
• History of severe immediate hypersensitivity reaction to any of the agents/ excipients of the study products.
• Women who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
• Subjects, for whom there are concerns that they will not reliably comply with the requirements for contraception, should not be enrolled into the study.
• Any serious underlying medical condition that could interfere with study medication and potential adverse events.

Where it is running

• Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (enrolling)
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland

Full record on ClinicalTrials.gov

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