Clinical trial · Interventional
Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
Clinical Study on the Safety and Efficacy of EBV CAR-T /TCR-T Cells in the Treatment of Recurrent / Refractory EBV Positive Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR | Drug | — | UNRESOLVED |
| PK Blood Collection | Behavioral | — | UNRESOLVED |
| TCR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CAR-T
- description
- Target A positivity was assigned to CAR-T cell therapy.
- interventionNames
- Behavioral: PK Blood Collection
- Drug: CAR
- type
- EXPERIMENTAL
- label
- TCR-T
- description
- Target A negative, Target B positive and Target C positive were assigned to TCR-T cell treatment group.
- interventionNames
- Behavioral: PK Blood Collection
- Drug: TCR
Primary outcomes (3)
- measure
- Dose Limiting Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (20)
- RESULTTaylor 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. PMID 25706097
- RESULTDalton 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. PMID 32157281
- RESULTCastillo 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. PMID 21212426
- RESULTDojcinov 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. PMID 29518976
- RESULTThompson 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. PMID 14871955
- RESULTKimura 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. PMID 30662890
- RESULTHealy 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. PMID 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.