Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697926
• Other study ID #: 2022105
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Jian Chen, Ph.D
• Phone: +8621-64377134
• Email: chenjent[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Gender is not limited, age 18-75 years old;

2. Estimated survival is greater than 3 months;

3. Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;

4. Patients with head and neck cancer whose tumor tissue can be surgically harvested;

5. Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

1. Infected or had been infected with COVID-19;

2. Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;

3. Patients with head and neck cancer who had received the following treatments:

The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;

4. Other situations that are not appropriate to be included in the clinical trial.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• No intervention
This is a preclinical study. No intervention will be performed.

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical prognosis	Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.	5 year postsurgery