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

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05697926

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experiment The excess tumor tissue from patients following surgical resection will be collected for further analysis.	Other: No intervention This is a preclinical study. No intervention will be performed.

Arm

Intervention/Treatment

Experiment

The excess tumor tissue from patients following surgical resection will be collected for further analysis.

Other: No intervention

This is a preclinical study. No intervention will be performed.

Outcome Measures

Primary Outcome Measures

Clinical prognosis [5 year postsurgery]
Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Gender is not limited, age 18-75 years old;
Estimated survival is greater than 3 months;
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;
Patients with head and neck cancer whose tumor tissue can be surgically harvested;
Volunteer to join the study and sign the informed consent.

Exclusion Criteria:

Infected or had been infected with COVID-19;
Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
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;

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

Eye & ENT Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eye & ENT Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT05697926

Other Study ID Numbers:

2022105

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eye & ENT Hospital of Fudan University

TCR-T therapy

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jan 26, 2023