EBV-TCR-T（YT-E001）for Patients With EBV-positive Recurrent or Metastatic NPC

Inclusion Criteria:

1. ≥18 years old;

2. Sign an informed consent before undertaking any trial-related activities;

3. NPC patients diagnosed by licensed pathologist, EBV DNA copy number >500.

4. Received at least one run of standard therapy (surgery, chemo, radiation and targetedtherapy) or first line and second line treatment failure;

5. HLA-A*0201/2402/1101;

6. ECOG score 0-2；Life expectancy is longer than 3 months;

7. No Chinese herbal medicine usage within 4 weeks before enrollment;

8. Lab test results meet the following requirements: White blood cell count≥4.0×109/L; ANC≥1.5 ×109/L; PLT≥100 ×109/L; Hemoglobin≥90g/L;Prothrombin time or INR ≤1.5× normal upper limit, except taking anticoagulant therapy;PTT≤1.5× normal upper limit；AST≤3×ULN; ALT≤3×ULN; ALP≤3×ULN; TBIL≤1.5×ULN。

9. Levels of calcium, potassium, and magnesium in serum are within the normal range;

10. Pregnancy test is negative for female subjects with reproductive capability beforeparticipating the study Female subjects must consent using birth control during thestudy or prohibit any homo or heterosexual behavior;

11. Can regularly visit the research institutions for tests, evaluations, and monitoringthroughout the study period.

Exclusion Criteria:

1. Received major surgery, conventional chemotherapy, large-area radiotherapy, immunetherapy or any biological anti-tumor therapy within 4 weeks prior to the study;

2. Allergic to any components of the therapy;

3. Never recovered to <2 grade CTCAE from prior surgery or treatment-related adverseevents;

4. With two or other types of primary solid tumors;

5. Poorly managed hypertension (systolic blood pressure >160 mmHg and / or diastolicblood pressure > 90 mmHg) or clinically significant(for example, active)cardiovascular and cerebrovascular diseases such as cerebrovascular incident (within 6months prior to signing the informed consent), myocardial infarction (within 6 monthsprior to signing the informed consent), unstable angina, grade II or above heartfailure, Congestive, or severe arrhythmia can not be controlled by medication or has apotential impact on the study;

6. With other serious organic disease and/or mental illness;

7. With systemic active infections that need treatments, including active tuberculosis,HIV/HBV/HCV- positive or clinically active hepatitis A, B and C;

8. With autoimmune diseases: such as a history of inflammatory bowel disease (IBD) orother autoimmune diseases determined by the investigator to be unsuitable for thestudy (e.g. systemic lupus erythematosus (SLE), vasculitis, invasive pulmonarydisease);

9. Within 4 weeks prior the infusion, received chronic systemic steroid cortisone,Hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gammainterferon, GCSF, cyclosporine etc.);

10. History of organ allografts, autologous / allogeneic stem cell transplantation, andrenal replacement therapy;

11. With central nervous system metastasis.

12. With uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lungdisease, or liver failure;

13. Pregnant or lactating female patients;

14. Received concomitant medication prohibited by the protocol;

15. With any medical condition or disease determined by the investigators that may bedetrimental to this trial;