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

NCT ID: NCT05697926

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experiment

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

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Chen, Ph.D

Role: CONTACT

+8621-64377134

Facility Contacts

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Jian Chen, phD

Role: primary

008618917785406

Other Identifiers

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2022105

Identifier Type: -

Identifier Source: org_study_id

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