EBV CAR-T Cells for Nasopharyngeal Carcinoma

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC

Inclusion Criteria:1)Voluntarily sign written informed consent;2)Age ≥18, ≤75 years old, male and female;3 )Estimated survival ≥ 3 months;4) ECOG physical fitness score was 0-2;5) EBV positive nasopharyngeal carcinoma was diagnosed;6) Positive target detection;7) At least one measurable lesion according to RECIST V1.1 solid tumor evaluation criteria;8) Patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line or higher systemic therapy;9) Monopheresis or venous blood collection venous access can be established, and there are no other contraindications for blood cell separation;10) Full organ and bone marrow function,11) Toxicity and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);12) Fertile subjects (male or female) must use effective medical contraception during the study period and for 6 months after the end of administration. In female subjects of reproductive age, a negative pregnancy test should be performed within 72 h prior to the first dose.Exclusion Criteria:1) There are active CNS metastases (except those stabilized by treatment);2)HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative test ≥1000cps/ mL), HCV antibody positive and HCV RNA positive;3) Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;4) subjects with severe autoimmune diseases and long-term use of immunosuppressants;5) Within 14 days prior to enrollment, there were active or uncontrollable infections requiring systemic treatment;6) Any unstable systemic disease7) Complicated with lung, brain, kidney and other important organ dysfunction;8) Subjects have undergone major surgery or trauma in the 4 weeks prior to receiving cell therapy, or are expected to undergo major surgery during the study period;9) Subjects received their last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, or immunotherapy) within 4 weeks prior to receiving cell therapy;10) The subject currently has or has had other malignancies that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignancies with disease-free survival of more than 5 years;11) T cells modified with chimeric antigen receptor (CAR T, TCR-T) within six months;12) Combined graft versus host disease (GVHD);13) Subjects who were receiving systemic steroids prior to screening and determined by the investigator to require long-term systemic steroid use during treatment (other than inhalation or topical use); And subjects who were treated with systemic steroids (except for inhalation or topical use) within 72 h prior to cell infusion;14) A history of severe allergies or allergies;15) Subjects requiring anticoagulant therapy;16) Women who are pregnant or breast-feeding, or have a pregnancy plan within six months (for both men and women);17) Researchers believe that there are other reasons not to include patients in the treatment.