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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\) Immunohistochemically documented NY-ESO-1 expression, defined as ≥ 1+ expression on either archival or fresh tumor tissue by immunohistochemistry, in ≥50% of the sampled tumor tissue.

• Patients with sarcoma, who have received at least one line of standard therapy (if available) and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.

• Patients with metastatic melanoma:

∙ Without proto-oncogene B-Raf (BRAF) mutation who have received at least one line of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.

‣ With BRAF mutation who have received at least two lines of standard therapy and failed to respond, progressed or were intolerant to that therapy, will be eligible. If the participant refuses or is, in the opinion of the investigator, ineligible for these treatments, the reason must be documented in the medical record.

• Patient must be HLA-A\*0201 and/or HLA-A\*0205 positive, as identified by high-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.

• Age ≥ 18 years

• Able to undergo apheresis

• At least one lesion accessible to biopsy for translational research (TR) at D30, without putting the patient at unusual risk.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Life expectancy of greater than 12 weeks.

• Radiologically measurable disease (as per RECIST v1.1).

⁃ Adequate organ function

Locations
Other Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Centre Hospitalier Universitaire Vaudois (CHUV)
NOT_YET_RECRUITING
Lausanne
Contact Information
Primary
Bernhard Gentner, MD
Bernhard.Gentner@chuv.ch
+4179 556 90 20
Backup
Virginie Zimmer, Study Coordinator
virginie.zimmer@chuv.ch
+41 21 314 97 09
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2029-06
Participants
Target number of participants: 9
Treatments
Other: Single arm study
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Vaudois

This content was sourced from clinicaltrials.gov