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Nasopharyngeal CarcinomaEarly Phase 1NCT05587543

Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma

A Early Phase 1 study testing PK Blood Collection, CAR and TCR in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study was a single-arm, open-label, "3 + 3" dose-escalation Exploratory research. The patients were divided into two groups: EBV TCR-T-cell Group and EBV CAR-T-cell group. The EBV CAR-T-treated group received three progressively increasing dose levels (3.0 × 106 cells/kg, 9.0 × 106 cells/kg, 1.5 × 107 cells/kg)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
PK Blood Collection, CAR and TCR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
28 Dec 2022to Oct 2030
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) ;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongmei Ji, Doctorate contact

13564183928

jidongmei2000@hotmail.com

China1 site, 1 recruiting

  • Fudan University

    Shanghai

    Dongmei Ji, doctor, 13564183928, jidongmei2000@hotmail.com

    Dongmei Ji, doctor

    Recruiting

Other trials in China

About this study

Official title: Clinical Study on the Safety and Efficacy of EBV CAR-T /TCR-T Cells in the Treatment of Recurrent / Refractory EBV Positive Nasopharyngeal Carcinoma

This study was a single-arm, open-label, "3 + 3" dose-escalation Exploratory research. The patients were divided into two groups: EBV TCR-T-cell Group and EBV CAR-T-cell group. The EBV CAR-T-treated group received three progressively increasing dose levels (3.0 × 106 cells/kg, 9.0 × 106 cells/kg, 1.5 × 107 cells/kg) of EBV CAR-T-cell therapy; The EBV TCR-T-cell group received three progressively increasing doses (5.0 × 106 cells/kg, 1.5 × 107 cells/kg, 3.0 × 107 cells/kg) of EBV TCR-T-cell therapy.

Read the detailed description

Each subject was observed for at least 4 weeks after cell reinfusion (DLT observation period) . A minimum of three participants should be included in each dose group, and two or more participants should not be included in each dose group at the same time, each subject should not be enrolled until the first 1 subject did not experience a grade 3 or higher adverse event (CTCAE5.0) related to the study drug during the DLT observation period. Three or six subjects were enrolled in each dose group, depending on the occurrence of DLT. If three subjects in one dose group did not experience DLT, three subjects were enrolled in the next higher dose group; if one of three subjects experienced DLT, three more subjects were enrolled in the dose group; Expanded to 6 subjects; if only 1 of the 6 subjects after amplification produced a DLT, then 3 subjects were enrolled into the next higher dose; If a DLT occurred in ≥2 of the 6 subjects after amplification, then the dose was specified to be higher than the MTD (MTD defined as the highest dose at which a DLT occurred in ≤1/6 subjects) , new subjects were included in the previous lower dose (tolerated dose) group until the lower dose group reached 6 subjects. If DLT occurred in ≤1/6 of the subjects, the lower dose group was defined as MTD or the best effective dose. A total of six subjects received the maximum tolerated dose. In the course of the study, the researcher can combine the safety and preliminary efficacy data of the enrolled subjects, and take the safety of the subjects and the maximum benefit of the disease as the premise, study treatment was performed at the maximum tolerated dose or other doses determined by the investigator.

Being tested
PK Blood Collection, CAR, TCR
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PK Blood CollectionBehavioural

    All subjects were subjected to PK blood sampling as prescribed by the protocol.

  • CARDrug

    Also called CAR-T cell therapy

    Target A positive subjects will receive CAR-T cell therapy.

  • TCRDrug

    Also called TCR -T cell therapy

    Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.

Study groups in NCT05587543
Study groupRoleWhat they receive
CAR-TExperimentalTarget A positivity was assigned to CAR-T cell therapy.
Receives: Behavioral: PK Blood Collection; Drug: CAR
TCR-TExperimentalTarget A negative, Target B positive and Target C positive were assigned to TCR-T cell treatment group.
Receives: Behavioral: PK Blood Collection; Drug: TCR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities

    Analysis based on clinical trial data of subjects

    Measured: one year

  2. MTD or the best effective dose

    Analysis based on clinical trial data of subjects

    Measured: one year

  3. Incidence of AE、SAE、AESI

    Analysis based on clinical trial data of subjects

    Measured: one year

Secondary outcomes (6)

  1. PK parameter：Cmax

    Analysis based on clinical trial data of subjects

    Measured: one year

  2. PK parameter：Tmax

    Analysis based on clinical trial data of subjects

    Measured: one year

  3. ORR

    Analysis based on clinical trial data of subjects

    Measured: one year

  4. DCR

    Analysis based on clinical trial data of subjects

    Measured: one year

  5. DOR

    Analysis based on clinical trial data of subjects

    Measured: one year

  6. PFS

    Analysis based on clinical trial data of subjects

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start28 Dec 2022
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
CAR-T、TCR-T
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587543
Sponsor's protocol ID
2207257-17
Status last verified
Mar 2026
First submitted
27 Sep 2022
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taylor GS, Long HM, Brooks JM, Rickinson AB, Hislop AD. The immunology of Epstein-Barr virus-induced disease. Annu Rev Immunol. 2015;33:787-821. doi: 10.1146/annurev-immunol-032414-112326. Epub 2015 Feb 11.

    PubMed 25706097

  • Dalton T, Doubrovina E, Pankov D, Reynolds R, Scholze H, Selvakumar A, Vizconde T, Savalia B, Dyomin V, Weigel C, Oakes CC, Alonso A, Elemento O, Pan H, Phillip JM, O'Reilly RJ, Gewurz BE, Cesarman E, Giulino-Roth L. Epigenetic reprogramming sensitizes immunologically silent EBV+ lymphomas to virus-directed immunotherapy. Blood. 2020 May 21;135(21):1870-1881. doi: 10.1182/blood.2019004126.

    PubMed 32157281

  • Castillo JJ, Beltran BE, Miranda RN, Paydas S, Winer ES, Butera JN. Epstein-barr virus-positive diffuse large B-cell lymphoma of the elderly: what we know so far. Oncologist. 2011;16(1):87-96. doi: 10.1634/theoncologist.2010-0213. Epub 2011 Jan 6.

    PubMed 21212426

  • Dojcinov SD, Fend F, Quintanilla-Martinez L. EBV-Positive Lymphoproliferations of B- T- and NK-Cell Derivation in Non-Immunocompromised Hosts. Pathogens. 2018 Mar 7;7(1):28. doi: 10.3390/pathogens7010028.

    PubMed 29518976

  • Thompson MP, Kurzrock R. Epstein-Barr virus and cancer. Clin Cancer Res. 2004 Feb 1;10(3):803-21. doi: 10.1158/1078-0432.ccr-0670-3.

    PubMed 14871955

  • Kimura H, Fujiwara S. Overview of EBV-Associated T/NK-Cell Lymphoproliferative Diseases. Front Pediatr. 2019 Jan 4;6:417. doi: 10.3389/fped.2018.00417. eCollection 2018.

    PubMed 30662890

  • Healy JA, Dave SS. The Role of EBV in the Pathogenesis of Diffuse Large B Cell Lymphoma. Curr Top Microbiol Immunol. 2015;390(Pt 1):315-37. doi: 10.1007/978-3-319-22822-8_13.

    PubMed 26424652

  • Mao Y, Zhang DW, Zhu H, Lin H, Xiong L, Cao Q, Liu Y, Li QD, Xu JR, Xu LF, Chen RJ. LMP1 and LMP2A are potential prognostic markers of extranodal NK/T-cell lymphoma, nasal type (ENKTL). Diagn Pathol. 2012 Dec 13;7:178. doi: 10.1186/1746-1596-7-178.

    PubMed 23237707

  • Wang ZY, Liu QF, Wang H, Jin J, Wang WH, Wang SL, Song YW, Liu YP, Fang H, Ren H, Wu RY, Chen B, Zhang XM, Lu NN, Zhou LQ, Li YX. Clinical implications of plasma Epstein-Barr virus DNA in early-stage extranodal nasal-type NK/T-cell lymphoma patients receiving primary radiotherapy. Blood. 2012 Sep 6;120(10):2003-10. doi: 10.1182/blood-2012-06-435024. Epub 2012 Jul 23.

    PubMed 22826562

  • Cho SG, Kim N, Sohn HJ, Lee SK, Oh ST, Lee HJ, Cho HI, Yim HW, Jung SE, Park G, Oh JH, Choi BO, Kim SW, Kim SW, Chung NG, Lee JW, Hong YS, Kim TG. Long-term Outcome of Extranodal NK/T Cell Lymphoma Patients Treated With Postremission Therapy Using EBV LMP1 and LMP2a-specific CTLs. Mol Ther. 2015 Aug;23(8):1401-1409. doi: 10.1038/mt.2015.91. Epub 2015 May 28.

    PubMed 26017177

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.

    PubMed 31178151

  • Wang L, Tian WD, Xu X, Nie B, Lu J, Liu X, Zhang B, Dong Q, Sunwoo JB, Li G, Li XP. Epstein-Barr virus nuclear antigen 1 (EBNA1) protein induction of epithelial-mesenchymal transition in nasopharyngeal carcinoma cells. Cancer. 2014 Feb 1;120(3):363-72. doi: 10.1002/cncr.28418. Epub 2013 Nov 4.

    PubMed 24190575

  • Zhu S, Chen J, Xiong Y, Kamara S, Gu M, Tang W, Chen S, Dong H, Xue X, Zheng ZM, Zhang L. Novel EBV LMP-2-affibody and affitoxin in molecular imaging and targeted therapy of nasopharyngeal carcinoma. PLoS Pathog. 2020 Jan 6;16(1):e1008223. doi: 10.1371/journal.ppat.1008223. eCollection 2020 Jan.

    PubMed 31905218

  • Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.

    PubMed 31150573

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PK Blood Collection, CAR and TCR in people with Nasopharyngeal Carcinoma, run by Fudan University 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Apr 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongmei Ji, Doctorate (13564183928, jidongmei2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05587543, which also lists 20 linked publications.

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 2 Apr 2026.

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