Head and Neck Squamous Cell CarcinomaPhase 1/2NCT04139057
EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC
A Phase 1/2 study testing EBV-specific TCR-T cell with anti-PD1 auto-secreted element in people with Head and Neck Squamous Cell Carcinoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- EBV-specific TCR-T cell with anti-PD1 auto-secreted element
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 15 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official 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
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
- Being tested
- EBV-specific TCR-T cell with anti-PD1 auto-secreted element
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-specific TCR-T cell with anti-PD1 auto-secreted elementDrug
Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element
| Study group | Role | What they receive |
|---|---|---|
| EBV TCR-T | Experimental | EBV-specific TCR-T cell with anti-PD1 auto-secreted element Receives: Drug: EBV-specific TCR-T cell with anti-PD1 auto-secreted element |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerated Dose
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Mar 2019
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Responsible party
- Principal investigator, Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
- Investigators
- Bo Zhu, MD, PhD, Principal investigator, Army Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139057
- Sponsor's protocol ID
- XQDC20191001
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04139057
- Acronym / sponsor ID
- XQDC20191001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV TCR-T | Experimental | Drug: EBV-specific TCR-T cell with anti-PD1 auto-secreted elementEBV-specific TCR-T cell with anti-PD1 auto-secreted element |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBV-specific TCR-T cell with anti-PD1 auto-secreted elementPatients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element | Drug | EBV TCR-T |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Zhu, MD, PhD principal investigator
Army Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EBV-specific TCR-T cell with anti-PD1 auto-secreted element in people with Head and Neck Squamous Cell Carcinoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum Tolerated Dose (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.