Supercharged immune cells take on Hard-to-Treat head and neck cancer
NCT ID NCT04139057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tested a new treatment for people with Epstein-Barr virus (EBV)-positive head and neck cancer that has spread or come back. The treatment uses specially engineered immune cells (TCR-T cells) that recognize EBV on cancer cells and also release a PD1 blocker to help them work better in the tumor environment. Ten participants received different doses to find the safest and most effective dose. The goal was to see if these cells could control the cancer, but ongoing management is still needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037, China
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Other studies related to the condition(s) this trial covers.
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