CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 18 target
Drug / intervention
TC-N201 cells +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05881525
NCT05881525Phase 1RecruitingUpdate OverdueUpdated 11mo ago · Completion was 6mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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.

TCRCure Biopharma Ltd.·interventional·Posted May 31, 2023·Updated Jul 16, 2025

In Brief

A Phase 1 clinical trial evaluating TC-N201 cells, IL-2, and 3 other interventions for Advanced Solid Tumors. Currently recruiting, targeting 18 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesChina
CollaboratorsCancer Institute and Hospital, Chinese Academy of Medical Sciences

Timeline

Phase 1Recruiting
2024202520262027
First PostedMay 31, 2023
Enrollment StartJun 1, 2023
Primary CompletionDec 1, 2025
Study CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 3.1 years ago

Interventions

TC-N201 cellsbiological

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.

IL-2drug

Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.

Fludarabinedrug

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Cyclophosphamidedrug

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Nab-paclitaxeldrug

Part of the non-myeloablative lymphocyte-depleting preparative regimen.