NCT04139057CompletedPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 20 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 10 (actual)
First submitted: 23 Oct 2019
Start date: 1 Mar 2019
Primary completion date: 15 Jan 2026
Lead sponsor: Xinqiao Hospital of Chongqing
Diseases: Head and neck cancer
NCT number: NCT04139057

What you commit to

Study type: Interventional · Phase 1/2
Participants enrolled: 10
From 1 Mar 2019 to the primary completion date, 15 Jan 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids

Other illness

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
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

Other

Patients with symptomatic brain metastasis
Researchers do not consider it appropriate to participate in this trial
Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment

Who the study is looking for

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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Oncology, Xinqiao Hospital Coordinator of this site? Confirm its status	Chongqing	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.