Using engineered T cells to treat EBV-positive head and neck cancer

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

This study is testing a new treatment using specially designed T cells to see if they can help patients with EBV-positive head and neck cancer fight their disease better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (ChongQing, Chongqing)
• Trial ID: NCT04139057 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of engineered T cells that specifically target Epstein-Barr virus (EBV) antigens in patients with EBV-positive head and neck squamous cell carcinoma (HNSCC). The approach involves creating T cells that can recognize and attack cancer cells presenting EBV antigens, while also incorporating an anti-PD1 element to counteract tumor-induced immune suppression. The trial aims to evaluate the safety and efficacy of this innovative immunotherapy in patients with recurrent or metastatic disease. By targeting the unique characteristics of EBV-related cancers, the study seeks to improve treatment outcomes for patients who have limited options.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed EBV-positive HNSCC who are expected to live longer than 12 weeks and have a performance status of 0-2.

Not a fit: Patients with symptomatic brain metastasis or other uncontrolled malignancies may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with EBV-positive head and neck cancer.

How similar studies have performed: While engineered T cell therapies have shown promise in hematological cancers, their application in solid tumors like HNSCC is still being explored, making this approach relatively novel.

Eligibility criteria

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

Where this trial is running

ChongQing, Chongqing

• Department of Oncology, Xinqiao Hospital — ChongQing, Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Bo Zhu, MD, PhD — Army Medical University, China
• Study coordinator: Qingzhu Jia, MD

Conditions Head and Neck Squamous Cell Carcinoma