Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma
This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma
• 1\. Sign the written informed consent voluntarily;
• 2\. Age ≥ 18, ≤ 75, male or female;
• 3.Expected life ≥ 3 months
• 4\. The physical condition score of the Eastern Tumor Cooperative Organization (ECOG) is 0-2;
• 5.Biopsy sample or pathological wax slice test (within 1 year before signing the informed consent): target test positive
• 6\. According to RECIST v1.1 solid tumor evaluation criteria, there is at least one measurable lesion;
• 7\. Patients with recurrent/metastatic nasopharyngeal carcinoma who have received second-line or above system treatment failure in the past (Recurrence of nasopharyngeal carcinoma: nasopharyngeal carcinoma confirmed by pathology, after radical radiotherapy, the clinical tumor disappears completely, and after 6 months of treatment, local tumors with the same pathological type as the original tumor reappear; metastasis of nasopharyngeal carcinoma: tumor cells transfer from the primary site to distant organs through various ways, such as blood and lymph, and form tumor metastasis focus);
• 8\. It is possible to establish a single blood collection or venous blood collection channel, and there is no other blood cell separation contraindication;
• 9\. It has sufficient organ and bone marrow functions, as defined below
⁃ routine blood test
⁃ Neutrophil count (NEUT #) ≥ 1.0 × 10\^9/L
⁃ Platelet count (PLT) ≥ 80 × 10\^9/L
⁃ Hemoglobin concentration ≥ 90g/L
⁃ Liver function: subjects without liver metastasis
⁃ Aspartate aminotransferase (AST) ≤ 2.5 × Upper limit of normal value (ULN)
⁃ Alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal value (ULN)
⁃ Total bilirubin (TBIL) ≤ 1.5 × ULN
⁃ Liver function: subjects with liver metastasis
⁃ Aspartate aminotransferase (AST) ≤ 5 × Upper limit of normal value (ULN)
⁃ Alanine aminotransferase (ALT) ≤ 5 × Upper limit of normal value (ULN)
⁃ Liver function: subjects with liver metastasis or Gilbert syndrome
⁃ Total bilirubin (TBIL) ≤ 2 × ULN
⁃ renal function
⁃ Creatinine clearance rate (CCR) ≥ 50mL/min
⁃ Coagulation function
⁃ International normalized ratio (INR) ≤ 1.5 × ULN
⁃ Activated partial thromboplastin event (APTT) ≤ 1.5 × ULN
• 10\. Toxic side effects left by early anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ Level 1 (CTCAE5.0);
• 11\. During the study period and within 6 months after the last administration, subjects with fertility (male or female) must take effective medical contraceptive measures. Female subjects of childbearing age must have a pregnancy test within 72 hours before the first administration, and the result is negative.