BGT007 Cell Treatment of Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring CAR-T, nasopharyngeal carcinoma, recurrent/metastatic nasopharyngeal carcinoma
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Active central nervous system metastasis (except those that are stable after treatment); 2. HIV positive or HBsAg positive, HBV DNA copy number is positive (quantitative test ≥ 1000 cps/ml) or HCV antibody is positive and HCV RNA is positive; 3. Those who have mental or psychological diseases and cannot cooperate with the treatment and efficacy evaluation; 4. Subjects with severe autoimmune diseases and long-term application of immunosuppressants; 5. There is active infection or uncontrollable infection requiring systemic treatment within 14 days before signing the informed consent form; 6. Any unstable systemic disease (including but not limited to): Active infection (except local infection); Unstable angina pectoris; Cerebrovascular ischemia or cerebrovascular accident (within 6 months before screening); Myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association [HYHA] classification ≥ Ⅲ); Serious arrhythmia requiring drug treatment; Heart disease needs treatment or hypertension is out of control after treatment (blood pressure>160mmHg/100mmHg); 7. Complicated with dysfunction of lung, brain, kidney and other important organs; 8. Subjects had undergone major surgery or severe trauma within 4 weeks before signing the informed consent form, or were expected to undergo major surgery during the study period. 9. Subjects received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before signing the informed consent form; 10. The subject currently suffers from or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer or skin basal cell cancer, and other malignant tumors with a disease-free survival period of more than 5 years; 11. Have received T cells (including CAR-T and TCR-T) modified by chimeric antigen receptor within half a year before signing the informed consent form; 12. Graft versus host disease (GVHD) 13. Subjects who were receiving systemic steroid treatment before signing the informed consent form and who were judged by the investigator to need long-term use of systemic steroid treatment during the treatment period (except for inhalation or local use); And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or local use); 14. Serious allergy or allergy history 15. Subjects requiring anticoagulation treatment 16. Pregnant or lactating women, or have a pregnancy plan within six months (for both men and women); 17. The investigator believes that there are other reasons that cannot be included in the treatment
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
BGT007 Cell Injection
In this study, 23 patients diagnosed with recurrent/metastatic nasopharyngeal carcinoma will receive a single intravenous infusion of BGT007 cells after enrollment, with a dose of 5.0 × 10^5cells/kg,1.0 × 10^6cells/kg,3.0 × 10^6cells/kg,6.0 × 10^6cells/kg,1.0 × 10^7cells/kg。 One subject was enrolled in each of the first two dose groups, and the other three dose groups were enrolled in accordance with the conventional "3+3" dose increase.