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

Last updated: November 20, 2024
Sponsor: PharmaEssentia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT06665776
TCRT-HR2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bylocal regulations).

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

  4. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;

  5. Hepatocellular carcinoma;

  6. Lung squamous cell carcinoma;

  7. Synovial sarcoma;

  8. Triple-negative breast cancer;

  9. Esophageal squamous cell carcinoma;

  10. Cervical cancer;

  11. Ovarian cancer

  12. Patient who received standard curative or palliative therapy including but notlimited to any targeted therapy based on mutation status for their cancer, orpatient with advanced solid tumors for which there is no accepted therapy, standardtherapies are no longer effective, or the patient refuses additional standardtherapy.

  13. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

  14. Body weight ≥ 50 Kg.

  15. Life expectancy of ≥ 6 months.

  16. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, fromeither fresh or archival tissue

Exclusion

Exclusion Criteria:

  1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease orAIDS).

  2. Uncontrolled intercurrent illness which is not suitable for enrollment at thediscretion of the investigator, including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, unstablecardiac arrhythmia, psychiatric illness, or social situations that would limitcompliance with study requirements.

  3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured ofthe other cancer [disease free period > 6 months] and currently has only oneresearch 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 forenrollment at the discretion of the investigator.

Study Design

Total Participants: 1200
Study Start date:
March 14, 2023
Estimated Completion Date:
December 31, 2025

Study Description

T cell receptor (TCR)-engineered T cells with high affinity to NY-ESO-1 epitope presented by HLA-A02:01 are potential therapeutic strategy against solid tumor, which show exciting results in several clinical studies. However, the prevalence of patients expressing HLA-A02:01 and NY-ESO-1 in Taiwanese population is still unknown. This research aims to explore the prevalence of cancer patients expressing HLA-A02:01 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-A02:01 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.

Connect with a study center

  • Chang Gung Memorial Hospital, Chiayi Branch

    Chiayi,
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.