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

NCT06889766 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

NY-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. Cohort 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. Cohort 2 : Patients will receive a fixed dose of 3x10\^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations. Cohort 3: Patients will receive a fixed dose of 6x10\^8 transduced LauT-1 cells (i.e. CD3+vβ13.1+) split over 2 administrations.

RADIATION

Low-dose irradiation

1Gy will be administered using tomotherapy (Accuray) to all irradiable lesions, to all cohorts before the (first) LauT-1 infusion.

DRUG

Non-myeloablative lymphodepleting chemotherapy

Cohort 1: Fludarabine (30 mg/m2 per day, 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). Cohorts 2 and 3: Fludarabine (30 mg/m2 per day, from D-6 to D-3) and cyclophosphamide (900 mg/ m2 x 2 days, on days -6 and -5) are administered as an IV infusion.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889766 on ClinicalTrials.gov