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

NCT05648994 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhiyong He · Fujian Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-02-29
Completion
2026-03-31

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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 NCT05648994 on ClinicalTrials.gov