RecruitingPhase 1NCT06889766

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


Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

9 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment called NY-ESO-1-redirected T cells — a type of personalized immunotherapy where your own immune cells are engineered to recognize and attack a protein found on certain tumors — in people with advanced melanoma (skin cancer) or sarcoma (cancers of bone or soft tissue). **You may be eligible if...** - Your tumor is confirmed to have melanoma or any type of sarcoma - Your tumor tests positive for a protein called NY-ESO-1 (found in at least 50% of tumor cells) - For sarcoma: you have already tried at least one standard therapy - For melanoma: you have tried approved treatments (including immunotherapy) **You may NOT be eligible if...** - Your tumor does not express the NY-ESO-1 protein - You have not yet tried standard therapies (if required for your tumor type) - You have significant heart, lung, or immune system problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNY-ESO-1 TCR redirected autologous T cell product

Ex vivo expanded autologous CD4+/CD8+ cells expressing the transgenic TCR I53F recognizing NY-ESO-1 peptides presented on tumor cells in the context of HLA-A\*02. 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.

RADIATIONLow-dose irradiation

1Gy will be administered using tomotherapy (Accuray) to all irradiable lesions.

DRUGNon-myeloablative lymphodepleting chemotherapy

Fludarabine (30 mg/m2 x 4 days, from D-6 to D-3) and cyclophosphamide (2400 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion. The cyclophosphamide dose may be reduced to 1800mg/m2 on days -6 and -5, if the patient has previously been exposed to significant cumulative doses of chemotherapy)


Locations(2)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

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NCT06889766


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