NCT05648994

TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• 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. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging 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. TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen. The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors. The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors. Eligibility: Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	TCR-T cells	patients will be administration of TCR-T cells
DRUG	Fludarabine	Part of the non-myeloablative lymphocyte-depleting preparative regime
DRUG	Cyclophosphamide Capsules	Part of the non-myeloablative lymphocyte-depleting preparative regime
DRUG	Albumin-bound paclitaxel	Part of the non-myeloablative lymphocyte-depleting preparative regime
DRUG	IL-2	Following cell infusion, the patient will be administration high-dose IL-2.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-02-01
• Completion: 2026-03-01
• First posted: 2022-12-13
• Last updated: 2022-12-13