NCT05881525

NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors

A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: TCRCure Biopharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.

Detailed description

This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy. Objective: To evaluate the safety and efficacy of TCR-T cells for the treatment of advanced solid tumors. Eligibility: Adults aging 18-70 with advanced solid tumors Design: Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Engineered T cells will be re-infused into the patient. Patients will stay in hospital and be evaluated

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	TC-N201 cells	T cells genetically engineered with a TCR targeting NY-ESO-1 (NY-ESO-1 TCR) that displays specific reactivity against HLA-A2+, NY-ESO-1+ target cells.
DRUG	IL-2	Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.
DRUG	Fludarabine	Part of the non-myeloablative lymphocyte-depleting preparative regimen.
DRUG	Cyclophosphamide	Part of the non-myeloablative lymphocyte-depleting preparative regimen.
DRUG	Nab-paclitaxel	Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-05-31
• Last updated: 2025-07-16

Locations

1 site across 1 country: China