Immune cell army targets Hard-to-Treat throat cancer
NCT ID NCT05587543
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether specially engineered immune cells (CAR-T and TCR-T) can safely fight Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma that has returned or not responded to treatment. About 24 adults will receive one of two types of cell therapy, with doses increased gradually to find the safest and most effective level. The main goals are to check for side effects and see if the treatment can control the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cells and TCR-T cells (engineered immune cells targeting EBV)
- What this could lead to
- If it works, this could point toward a new treatment option for people with hard-to-treat nasopharyngeal cancer that has come back or not responded to standard therapy.
- What could go wrong
- This is a very early (Phase 1) trial with only 24 participants, so it is primarily testing safety and dosing. The therapy may not shrink tumors, and there are risks of serious side effects from the cell infusions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- 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 75 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary written informed consent; * Age ≥18 years old, ≤75 years old, male and female; * Expected survival ≥3 months; * The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0-2; * Ebv-positive nasopharyngeal carcinoma was diagnosed by in situ hybridization with Ebers (Eber-fish) . * Pathological Paraffin section testing (within 5 years before signing the informed consent form) ; * At least one measurable lesion according to RECIST v1.1 criteria for solid tumors; * Recurrent/metastatic nasopharyngeal carcinoma patients who had previously failed second-line or more systemic therapy; * An apheresis or venous access can be established and there are no other contraindications to blood cell isolation; * CTCAE 5.0 was lower than grade 1 in the side effects of previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) * During the study period and up to 6 months after the end of the administration, fertile subjects -LRB-both male and female) were required to use effective medical contraception. For women of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the results were negative. Exclusion Criteria: * Active central nervous system metastases (except those that are stable after treatment); * HIV positive, HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 CPS/ml) , HCV antibody positive and HCV RNA positive; * Patients with mental or psychological disorders who can not cooperate with the treatment and evaluation of the curative effect; * Subjects with severe autoimmune disease and long-term use of immunosuppressants; * Active or uncontrolled infection requiring systemic therapy was present within 14 days prior to enrollment; * Any unstable systemic disease; * Complicated with dysfunction of important organs such as lung, brain and kidney. * Subjects had undergone major surgery or severe trauma within 4 weeks before receiving cell therapy, or were expected to undergo major surgery during the study period. * Participants received their last dose of radiation or anti-tumor therapy within 4 weeks of receiving the cell therapy. * Participants had or had had other cancers that were incurable for up to 3 years, except for cervical cancer in situ or skin basal-cell carcinoma, and other cancers that had disease-free survival of more than 5 years. * Treated with Chimeric antigen receptor t-cell therapy within six months. * Graft-versus-host disease (GVHD); * Subjects who were receiving systemic steroid therapy before screening and who required long-term systemic steroid therapy during treatment as determined by the investigator (with the exception of inhaled or topical use) ; And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or topical use) . * Severe allergies or a history of allergies; * Subjects requiring anticoagulant therapy; * Pregnant or lactating women, or a six-month pregnancy plan (for both men and women); * Researchers believe there are other reasons not to include people in treatment.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test