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

Recruiting

• Conditions: Solid Tumor Malignancy

• Registration Number: NCT06665776
• Lead Sponsor: PharmaEssentia

Brief Summary

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.

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 Timeline

• Study Start: 2023-03-14
• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (6)

Chang Gung Memorial Hospital, Chiayi Branch; 🇨🇳 Chiayi, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan