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NK/T-cell LymphomaEarly Phase 1Anti-EBV TCR-TNCT07162012

Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma

A Early Phase 1 study testing EBV TCR-T in people with NK/T-cell Lymphoma and Peripheral T-cell Lymphoma (PTCL), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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
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Trial summary

This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
EBV TCR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
20 Sep 2025to Sep 2029
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years, male or female.
  • HLA genotype at locus A is 11:01.
  • Disease diagnosis and status:
  • Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization [ISH] or fluorescence in situ hybridization [FISH]), with peripheral blood EBV viral load >10³ copies/mL by quantitative real-time PCR.
  • Disease types include but are not limited to:
  • NK/T-cell lymphoma (NK/TCL); Peripheral T-cell lymphoma (PTCL); Other types.
Show all 26Show fewer
  • Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).
  • Definition of refractory disease (meeting any of the following):
  • No partial remission (PR) after ≥4 cycles of standard therapy; No complete remission (CR) after ≥6 cycles of therapy; Failure to achieve CR after autologous hematopoietic stem cell transplantation; If best response is progressive disease (PD) or treatment is discontinued due to PD, no minimum cycle requirement applies.
  • Prior treatment requirements:
  • For relapsed/refractory PTCL or NK/TCL, patients must have received at least one prior line of systemic therapy. For relapsed/refractory NK/TCL, patients must have received an asparaginase-containing regimen (patients with stage I/II nasal NK/TCL according to the CA staging system must have also received radiotherapy).
  • Measurable disease: At least one measurable lesion according to the 2014 Lymphoma Response Evaluation Criteria:
  • Nodal lesions: longest diameter >15 mm on contrast-enhanced CT, MRI, or PET-CT;
  • Extranodal lesions: longest diameter >10 mm. For patients with bone-marrow-only involvement who have no measurable lesions on imaging, the presence of ≥5% lymphoma cells in bone marrow biopsy or flow cytometry can be considered an evaluable lesion.
  • Adequate organ function, defined as:
  • Hematologic: absolute neutrophil count ≥1×10⁹/L; hemoglobin ≥70 g/L; platelet count ≥50×10⁹/L;
  • Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN), and total bilirubin (TBIL) ≤ 1.5 × ULN (except when liver function abnormalities are attributable to the underlying disease);
  • Renal: serum creatinine ≤1.5× ULN;
  • Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
  • Coagulation: fibrinogen ≥1.0 g/L; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.
  • Expected survival >3 months.
  • ECOG performance status <3.
  • Contraception requirements:
  • No pregnancy planned during the treatment period;
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the end of treatment.
  • Willingness to participate in the study, ability to sign informed consent, comply with the study protocol, and availability of peripheral venous access for lymphocyte collection.

Who cannot join

  • Subjects meeting any of the following conditions will not be eligible for enrollment:
  • History of other malignancies, except for:
  • Basal cell carcinoma of the skin;
  • Squamous cell carcinoma of the skin;
  • Superficial bladder cancer;
  • Carcinoma in situ of the cervix;
Show all 24Show fewer
  • Gastrointestinal mucosal carcinoma in situ;
  • Other malignancies considered acceptable by the investigator (must have received curative treatment with no recurrence within the past 5 years).
  • Recent anti-tumor therapy: less than 4 weeks since last anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local therapy), or less than 2 weeks since palliative radiotherapy.
  • Pregnant or breastfeeding women.
  • Presence of severe medical conditions such as intracranial hypertension, impaired consciousness, respiratory failure, or disseminated intravascular coagulation (DIC).
  • Severe organ dysfunction, including:
  • NYHA class IV cardiac function; Child-Pugh class C liver function; Creatinine clearance <60 mL/min (by Cockcroft-Gault formula); Baseline oxygen saturation <92%.
  • Known active infections or positive screening results for:
  • Hepatitis B virus (HBV): HBsAg positive, or HBcAb positive with HBV-DNA above the detection limit of the study center;
  • Hepatitis C virus (HCV): HCV antibody positive and HCV RNA ≥ upper limit of normal (ULN);
  • Human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibody positive;
  • Active tuberculosis (TB) (must be excluded by chest X-ray, sputum test, and clinical symptoms) or history of active TB;
  • Severe acute or chronic infections requiring systemic treatment.
  • Active central nervous system (CNS) disease (e.g., tumor metastasis, infection, demyelinating disease), including untreated lesions, progressive disease on imaging or symptoms requiring urgent intervention, or requiring high-dose immunosuppressive therapy for control.
  • Receiving systemic corticosteroid therapy prior to screening and judged by the investigator to require long-term systemic corticosteroid treatment during the study (excluding inhaled or topical use); or receiving systemic corticosteroid treatment within 72 hours before cell infusion (excluding inhaled or topical use).
  • Presence of graft-versus-host disease (GVHD), defined as grade ≥2 acute GVHD or moderate/severe chronic GVHD, or current use of immunosuppressive therapy.
  • History of severe allergic reactions to drugs or excipients required in this study, or history of allergy to tocilizumab.
  • Any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation.

Trial locations and contacts

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

Xianmin Song, Doctor contact

+86 18918029692

shongxm@139.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai

    Xianmin Song, Doctor, +86 18918029692, shongxm@139.com

    Yannan Jia, Doctor, +86 18918029692, landiao1223@126.com

    Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection for Treating Relapsed/Refractory EBV-positive Lymphoma Patients With HLA-A11:01

This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.

The study will also measure how the infused TCR-T cells expand and persist in the body, changes in EBV DNA levels and T-cell subgroups in the blood, and whether the treatment shows early signs of clinical benefit. Researchers will also explore whether the treatment causes an immune response against the infused cells.

Being tested
EBV TCR-T
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

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

  • EBV TCR-TDrug

    After signing the informed consent form and completing screening according to the inclusion/exclusion criteria, eligible subjects will be sequentially assigned to the following dose cohorts of TCR-T cells (single administration): 1×10⁶ TCR-T cells/kg, 2.5×10⁶ TCR-T cells/kg, 5×10⁶ TCR-T cells/kg, and 10×10⁶ TCR-T cells/kg.

    The first dose cohort (1×10⁶ TCR-T cells/kg) will use a rapid titration approach. If no significant safety issues occur within 28 days after infusion-defined as ≥Grade 3 non-hematologic toxicity, Grade 4 hematologic toxicity lasting more than 28 days (excluding disease- or chemotherapy-related causes), ≥Grade 2 neurotoxicity, or ≥Grade 3 cytokine release syndrome (CRS)-the next dose cohort will be initiated. If a dose-limiting toxicity (DLT) occurs, evaluation will be performed after 6 subjects have been treated.

    The subsequent three dose cohorts will follow a "3+3" dose-escalation design, with 3-6 subjects per cohort receiving a single infusion. For subjects in th

Study groups in NCT07162012
Study groupRoleWhat they receive
EBV-TCR-TExperimentalNot described
Receives: Drug: EBV TCR-T

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    To evaluate the incidence of dose-limiting toxicities (DLTs) of anti-EBV TCR-T cell injection in subjects with relapsed/refractory EBV-positive HLA-A11:01 lymphoma.

    Measured: treatment cycle (Day 1 to Day 28)

  2. Maximum Tolerated Dose (MTD)

    Determination of the maximum tolerated dose of anti-EBV TCR-T cell injection.

    Measured: From Day 1 of treatment until the end of the dose-escalation phase

  3. Recommended Phase 2 Dose (RP2D)

    Determination of the recommended dose for the expansion study based on safety, tolerability, and MTD.

    Measured: At the completion of the dose-escalation phase

Secondary outcomes (7)

  1. Expansion and persistence of EBV TCR-T cells

    To evaluate the in vivo expansion and persistence of anti-EBV TCR-T cells after infusion

    Measured: From Day 1 of infusion up to 24 months

  2. EBV DNA copies in peripheral blood

    To evaluate the EBV DNA copy number in peripheral blood after infusion of anti-EBV TCR-T cells.

    Measured: From Day 1 of infusion up to 24 months

  3. Changes in T-cell subsets in peripheral blood

    To evaluate the changes in peripheral blood T-cell subsets after infusion of anti-EBV TCR-T cells.

    Measured: From Day 1 of infusion up to 24 months

  4. Objective Response Rate (ORR)

    Proportion of subjects achieving complete response (CR) or partial response (PR) following treatment with anti-EBV TCR-T cells.

    Measured: At 3 months and 6 months after infusion

  5. Duration of Response (DOR)

    Duration of response in subjects with relapsed/refractory EBV-positive lymphoma treated with anti-EBV TCR-T cells.

    Measured: From the first documented response (CR or PR) until disease progression/relapse or death, up to 24 months

  6. Progression-Free Survival (PFS)

    Progression-free survival following anti-EBV TCR-T cell treatment.

    Measured: From infusion until documented disease progression or death, up to 24 months

  7. Overall Survival (OS)

    Overall survival following anti-EBV TCR-T cell treatment.

    Measured: From infusion until death from any cause, up to 24 months

Timeline

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

  1. First posted9 Sep 2025
  2. Study start20 Sep 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (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
Not applicable
Intervention model
Single group
Model description
Using a rapid titration combined with a "3+3" design
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162012
Sponsor's protocol ID
SHSYXY-EBV-TCR-T-202505
Acronym
Anti-EBV TCR-T
Status last verified
Nov 2025
First submitted
31 Aug 2025
Last updated
2 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chou CC, Tsao CF, Liao CK, You HL, Wang MC, Huang WT. Analysis of latent T-cell epitopes in Epstein-Barr virus isolated from extranodal nasal-type natural killer/T-cell lymphoma in Taiwanese population. Exp Mol Pathol. 2021 Feb;118:104577. doi: 10.1016/j.yexmp.2020.104577. Epub 2020 Nov 23.

    PubMed 33242451

  • Barros MHM, Alves PDS. Contribution of the Epstein-Barr virus to the oncogenesis of mature T-cell lymphoproliferative neoplasms. Front Oncol. 2023 Sep 14;13:1240359. doi: 10.3389/fonc.2023.1240359. eCollection 2023.

    PubMed 37781191

  • Hinrichs CS, Restifo NP. Reassessing target antigens for adoptive T-cell therapy. Nat Biotechnol. 2013 Nov;31(11):999-1008. doi: 10.1038/nbt.2725. Epub 2013 Oct 20.

    PubMed 24142051

  • Heslop HE, Slobod KS, Pule MA, Hale GA, Rousseau A, Smith CA, Bollard CM, Liu H, Wu MF, Rochester RJ, Amrolia PJ, Hurwitz JL, Brenner MK, Rooney CM. Long-term outcome of EBV-specific T-cell infusions to prevent or treat EBV-related lymphoproliferative disease in transplant recipients. Blood. 2010 Feb 4;115(5):925-35. doi: 10.1182/blood-2009-08-239186. Epub 2009 Oct 30.

    PubMed 19880495

  • Okamoto A, Yanada M, Miura H, Inaguma Y, Tokuda M, Morishima S, Kanie T, Yamamoto Y, Mizuta S, Akatsuka Y, Yoshikawa T, Mizoguchi Y, Nakamura S, Okamoto M, Emi N. Prognostic significance of Epstein-Barr virus DNA detection in pretreatment serum in diffuse large B-cell lymphoma. Cancer Sci. 2015 Nov;106(11):1576-81. doi: 10.1111/cas.12812. Epub 2015 Oct 7.

    PubMed 26353084

  • Gao X, Li J, Wang Y, Liu S, Yue B. Clinical characteristics and prognostic significance of EBER positivity in diffuse large B-cell lymphoma: A meta-analysis. PLoS One. 2018 Jun 19;13(6):e0199398. doi: 10.1371/journal.pone.0199398. eCollection 2018.

    PubMed 29920566

  • Lu TX, Liang JH, Miao Y, Fan L, Wang L, Qu XY, Cao L, Gong QX, Wang Z, Zhang ZH, Xu W, Li JY. Epstein-Barr virus positive diffuse large B-cell lymphoma predict poor outcome, regardless of the age. Sci Rep. 2015 Jul 23;5:12168. doi: 10.1038/srep12168.

    PubMed 26202875

  • Song CG, Huang JJ, Li YJ, Xia Y, Wang Y, Bi XW, Jiang WQ, Huang HQ, Lin TY, Li ZM. Epstein-Barr Virus-Positive Diffuse Large B-Cell Lymphoma in the Elderly: A Matched Case-Control Analysis. PLoS One. 2015 Jul 29;10(7):e0133973. doi: 10.1371/journal.pone.0133973. eCollection 2015.

    PubMed 26222726

  • Ok CY, Papathomas TG, Medeiros LJ, Young KH. EBV-positive diffuse large B-cell lymphoma of the elderly. Blood. 2013 Jul 18;122(3):328-40. doi: 10.1182/blood-2013-03-489708. Epub 2013 May 6.

    PubMed 23649469

  • 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

  • Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.

    PubMed 27269947

  • Lim SH, Hong JY, Lim ST, Hong H, Arnoud J, Zhao W, Yoon DH, Tang T, Cho J, Park S, Ko YH, Kim SJ, Suh C, Lin T, Kim WS. Beyond first-line non-anthracycline-based chemotherapy for extranodal NK/T-cell lymphoma: clinical outcome and current perspectives on salvage therapy for patients after first relapse and progression of disease. Ann Oncol. 2017 Sep 1;28(9):2199-2205. doi: 10.1093/annonc/mdx316.

    PubMed 28911074

  • Grogg KL, Miller RF, Dogan A. HIV infection and lymphoma. J Clin Pathol. 2007 Dec;60(12):1365-72. doi: 10.1136/jcp.2007.051953.

    PubMed 18042692

  • Fox CP, Haigh TA, Taylor GS, Long HM, Lee SP, Shannon-Lowe C, O'Connor S, Bollard CM, Iqbal J, Chan WC, Rickinson AB, Bell AI, Rowe M. A novel latent membrane 2 transcript expressed in Epstein-Barr virus-positive NK- and T-cell lymphoproliferative disease encodes a target for cellular immunotherapy. Blood. 2010 Nov 11;116(19):3695-704. doi: 10.1182/blood-2010-06-292268. Epub 2010 Jul 29.

    PubMed 20671118

  • Kuppers R, Engert A, Hansmann ML. Hodgkin lymphoma. J Clin Invest. 2012 Oct;122(10):3439-47. doi: 10.1172/JCI61245. Epub 2012 Oct 1.

    PubMed 23023715

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing EBV TCR-T in people with NK/T-cell Lymphoma and Peripheral T-cell Lymphoma (PTCL), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 26 inclusion and 24 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 Dec 2025. 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 Xianmin Song, Doctor (+86 18918029692, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: treatment cycle (Day 1 to Day 28)). 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 NCT07162012, which also lists 15 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 Dec 2025.

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