BGT007 Cell Treatment of Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Collaborator: Guangzhou Bioresette Biomedical Technology Co., Ltd.
• Treatments: Cyclophosphamide; Fludarabine

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