Personalized TCR-T therapy development for head and neck cancer
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
This study is testing a new personalized treatment for head and neck cancer by using patients' tumor samples to create a therapy that fits their specific needs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05697926 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop personalized TCR-T therapy for patients with head and neck cancer by obtaining tumor samples and determining the reactive TCR clone sequences. It focuses on newly diagnosed patients or those with refractory recurrent advanced head and neck cancer who have not received prior treatments. The study will analyze the tumor tissue harvested surgically to tailor the therapy to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed or refractory recurrent head and neck cancer who can provide tumor samples.
Not a fit: Patients who have received prior treatments such as immune checkpoint inhibitors or chemotherapy within specified timeframes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with head and neck cancer.
How similar studies have performed: While personalized TCR-T therapy is a novel approach, similar immunotherapy strategies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jian Chen, Ph.D
- Email: chenjent@qq.com
- Phone: +8621-64377134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.