EBV CAR-T Cells for Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring CAR-T, nasopharyngeal carcinoma, Recurrent/refractory nasopharyngeal carcinoma
Eligibility Criteria
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 disease 7) 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.
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
CAR-T Cell Injection
A total of 24 patients with recurrent or refractory NPC received a single intravenous infusion of CAR-T cells at doses of 3.0 × 10^6cells/kg, 9.0 × 10^6cells/kg, and 1.5 × 10^7cells/kg, respectively, and were enrolled according to the conventional "3+3" dose escalation.