EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce nasopharyngeal cancers. To date, EBV-related head and neck squamous cell carcinoma (HNSCC) is still a major concern in east Asia, especially in China. Concurrent therapies for HNSCC have limited response rate and high chance of relapse. However, EBV-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented EBV antigen become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. One key mechanism of tumor-elicited suppression is the PDL1-PD1 interaction which induces T cell exhaustion. Therefore, TCR-T cells armed with a PD1 antagonist could further enhance the efficacy of TCR-T in solid cancers.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Oncology, Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Expected to live longer than 12 weeks
PS 0-2
Pathology confirmed as EBV positive HNSCC, either metastatic or recurrent disease
Creatinine <2.5mg/dl
ALT/AST is lower than three times ULN.
No contraindications of leukocyte collection
Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.
Understand this trial and have signed an informed consent

Exclusion criteria

Patients with symptomatic brain metastasis
With other uncontrolled malignant tumors.
Hepatitis B or Hepatitis C activity period, HIV infected patients
Any other uncontrolled disease that interferes with the trial
Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage
Untreated hypertension or hypertensive patients
A person with a history of mental illness that is difficult to control
Researchers do not consider it appropriate to participate in this trial
Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids
Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment
An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements

Treatment and study plan

EBV-specific TCR-T cell with anti-PD1 auto-secreted element

Drug

Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element

Primary outcomes

The Maximum Tolerated Dose

Time frame: 8 weeks

Verify the MTD of TCR-T cells for EBV antigen for treatment. 18 patients will be enrolled in this project, using a dose-escalation approach. The first group of patients will receive 5x10e6/kg TCR-T cells, the second group will receive 1x10e7/kg TCR-T cells, the third group will receive 5x10e7/kg TCR-T cells, the forth group will receive 1x10e8/kg. After confirmation of safety for 5×10e7 dose group, we then added IL-2 on this dose level for consecutive 6 patients. The remaining 6 pts are for enrollment of 1×10e8/kg dose level.

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

TCRCure Biopharma Ltd.

Registry information

Official study title

Single-Arm Trial of EBV-Specific TCR-T Cells With Anti-PD1 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Oct 25, 2019
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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