Relapsed/Refractory EBV Nasopharyngeal Carcinoma
Conditions
Interventions
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent; 2. Aged 18 to 70 years, both male and female; 3. Expected survival period >= 3 months; 4. Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2; 5. Diagnosed as EBV-positive nasopharyngeal carcinoma by EBERs (EBER-FISH) detected by in situ hybridization; 6. Pathological wax block sections (within 1 year after diagnosis) or fresh tissue samples: LMP2A positive and HLA typing: HLA-A*0201/2402/1101 positive; 7. According to RECISTv1.1 solid tumor evaluation criteria (nasopharyngeal carcinoma), at least one measurable lesion; 8. Patients with relapsed/refractory nasopharyngeal carcinoma who have received second-line or above systemic therapy in the past; 9. Venous access for apheresis or venous blood collection can be established, and there are no other contraindications for blood cell separation; 10. Have adequate liver and kidney and coagulation functions, defined as follows: (1) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 mL/min; (3) Coagulation function: International Normalized Ratio (INR)<=1.5xULN and Activated Partial Thromboplastin Time (APTT)<= 1.5 x ULN. 11. Toxic and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) <= grade 1 (CTCAE 5.0). 12. During the study period and within 6 months after the end of the administration, the subjects with fertility (regardless of men and women) must take effective medical contraceptive measures. For female subjects of childbearing age, a pregnancy test must be performed within 72 hours before the first dose, and the result is negative.
Exclusion criteria
Exclusion criteria: 1. There is active central nervous system metastasis (except those who have been stabilized after treatment); 2. HIV positive or Treponema pallidum positive, HBsAg positive and HBV DNA copy number positive (quantitative detection >= 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 disease and long-term use of immunosuppressive agents; 5. Within 14 days before enrollment, there is active infection or uncontrollable infection requiring systemic treatment; 6. Any unstable systemic disease (including but not limited to): unstable angina; cerebrovascular ischemia or cerebrovascular accident (within 6 months before screening); myocardial infarction (within 6 months before screening); congestion Heart failure (New York Heart Association [NYHA] classification >= grade III); severe arrhythmia requiring drug treatment; heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100mmHg); 7. Combined with dysfunction of important organs such as lung, brain and kidney; 8. Subjects have undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or are expected to undergo major surgery during the study period. 9. The subject received the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before receiving cell therapy 10. The subject currently has or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer in situ or skin basal cell carcinoma, and other malignant tumors with a disease-free survival period of more than 5 years; 11. Received chimeric antigen receptor-modified T cell (including CAR-T, TCR-T) therapy within six months; 12. Combined with graft-versus-host disease (GVHD); 13. Subjects who were receiving systemic steroid therapy before screening and who were judged by the investigator to need long-term use of systemic steroids during treatment (except inhalation or topical use); and those who used systemic steroid therapy within 72 hours before cell reinfusion test subjects (except for inhalation or topical use); 14. Severe allergies or history of allergies; 15. Subjects in need of anticoagulation therapy; 16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (universal); 17). The investigator believes that there are other reasons for not being included in the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerable dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| EBV TCR-T cells expand and continue in the body;Objective response rate; | — |
Countries
China
Contacts
Public ContactZhang Longzhen
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed