Clinical Study on the Safety and Efficacy of EBV CAR-T /TCR-T Cells in the Treatment of Recurrent / Refractory EBV Positive Nasopharyngeal Carcinoma
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.
• 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.