HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan

A Prospective Observational Human Subject Research to Explore the HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan

This is a prospective observational research to explore the frequency of Human leukocyte antigen A allele 02:01 (HLA*02:01) and the expression status of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) in cancer patients in Taiwanese population.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor Malignancy

Detailed Description

T cell receptor (TCR)-engineered T cells with high affinity to NY-ESO-1 epitope presented by HLA-A*02:01 are potential therapeutic strategy against solid tumor, which show exciting results in several clinical studies. However, the prevalence of patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population is still unknown. This research aims to explore the prevalence of cancer patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population. Eligible patients with triple-negative breast cancer, hepatocellular carcinoma, head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma, Lung squamous cell cancer, synovial sarcoma, esophageal squamous cell carcinoma, cervical cancer, or ovarian cancer will be enrolled. High resolution genotyping for HLA-A*02:01 and NY-ESO-1 expression status using IHC will be assessed in all enrolled patients. The frequency of HLA-A*02:01 allele and the prevalence of NY-ESO-1 positive expression will be analysed by pooled patient population and by specific tumor type.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Hsi-Chi Chang; Phone Number: +886-2-2655-7688; Email: angela_chang@pharmaessentia.com

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital, Chiayi Branch
  • Taichung, Taiwan, 407219
    • Recruiting
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University Hospital
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed diagnosis of any of the following solid tumor:

1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
2. Hepatocellular carcinoma;
3. Lung squamous cell carcinoma;
4. Synovial sarcoma;
5. Triple-negative breast cancer;
6. Esophageal squamous cell carcinoma;
7. Cervical cancer;
8. Ovarian cancer

Description

Inclusion Criteria:

1. Able to understand and voluntarily sign an informed consent form (ICF).
2. Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).

3. Confirmed diagnosis of any of the following solid tumor:

   1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
   2. Hepatocellular carcinoma;
   3. Lung squamous cell carcinoma;
   4. Synovial sarcoma;
   5. Triple-negative breast cancer;
   6. Esophageal squamous cell carcinoma;
   7. Cervical cancer;
   8. Ovarian cancer
4. Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
6. Body weight ≥ 50 Kg.
7. Life expectancy of ≥ 6 months.
8. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue

Exclusion Criteria:

1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
2. Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer [disease free period > 6 months] and currently has only one research targeted tumor can be enrolled.
4. Untreated or symptomatic brain metastasis.
5. History of organ transplantation or allogeneic stem cell transplantation.
6. Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of HLA-A*02:01 allele in patients with confirmed diagnosed solid tumor.	To explore the frequency of HLA-A*02:01 allele using genotyping with high resolution in all eligible patients with confirmed diagnosed solid tumor.	1 day
The prevalence of NY-ESO-1 positive expression in all tumor patients with HLA-A*02:01 allele.	To explore the prevalence of NY-ESO-1 positive expression using immunohistochemistry (IHC) in all patients with HLA-A*02:01 allele.	1 day

Collaborators and Investigators

• Sponsor: PharmaEssentia

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Solid tumor; NY-ESO-1; HLA-A*02:01
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TCRT-HR2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No