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

NCT ID: NCT04139057

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2026-01-15

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EBV TCR-T

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TCRCure Biopharma Ltd.

INDUSTRY

Sponsor Role: collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Qingzhu Jia, M.D.

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Zhu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Army Medical University, China

Locations

Department of Oncology, Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

XQDC20191001

Identifier Type: -

Identifier Source: org_study_id