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RECRUITING
NCT05881525
PHASE1

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

Sponsor: TCRCure Biopharma Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-06-01

Completion Date

2026-12

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

TCRCure Biopharma Ltd.

Chongqing, China