| Eligibility |
Inclusion Criteria:
1. Histologically confirmed nasopharyngeal carcinoma;
2. Be able to understand this study and have signed the informed consent;
3. Age >18 years old, <75 years old;
4. Expected survival period =3 months;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Epstein-Barr virus Encoded RNAs (EBER) positive in tumor tissue detected by in situ
hybridization (ISH or FISH):
7. By immunohistochemistry (IHC), the target in the pathological sample of the tumor
tissue is positive and >20%;
8. According to RECIST v1.1, there is at least one measurable lesion;
9. Patients must have failed to response at least 2 lines of the standard therapies
recommended by local NPC guidance, and without other therapy available.
10. Venous access for apheresis or blood collection can be established, without
contraindications for leukapheresis;
11. Having adequate organ and bone marrow function, as defined below:
Complete Blood Count Neutrophils (NEUT#) =1.0x10^9/L; Platelet (PLT) =80x10^9/L; Hemoglobin
=90g/L; Liver function: Without No liver metastasis Aspartate aminotransferase (AST) =2.5 x
Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) =2.5 x ULN; Total bilirubin
(TBIL) =1.5 x ULN; Liver Function: With liver metastasis Aspartate aminotransferase (AST)
=5 x ULN; Alanine aminotransferase (ALT) =5 x ULN; Liver Function: With liver metastasis or
Gilbert syndrome; Total bilirubin (TBIL) =2 x ULN; Creatinine Clearance Rate (CCR) = 50
mL/min; International Normalized Ratio (INR) =1.5xULN; Activated partial thromboplastin
time (APTT) =1.5xULN;
12. During the study period and within 6 months after the end of administration, the
subjects of childbearing potential (whether male or female) must use effective medical
contraceptive measures For female subjects of childbearing age, a pregnancy test must be
performed within 72 hours before cell infusion, and the result is negative.
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Exclusion Criteria:
1. Known or suspected being allergy to any of the agents used in this study.
2. Previously received anti-tumor treatments, including other anti-tumor investigational
drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation
therapy (except local radiation therapy for pain relief), etc., the treatment related
toxicity not recovered to baseline or CTCAE=0~1.
3. Received adoptive cellular immunotherapy (including CAR-T cells and T Cell Receptor-T
cells (TCR-T)) within 6months.
4. Confirmed central nervous system metastasis.
5. Confirmed extensive liver metastasis (the tumor volume is estimated to be=50% of the
total liver volume imaging).
6. Clinically significant active infections (e.g. Simple Urinary Tract Infection (UTl),
bacterial pharyngitis are allowed) or currently receiving IV antibiotics or have
received IV antibiotics with in 14 days prior to enrollment(Prophylaxis antibiotics,
antivirals and antifungals are permitted);
7. HBsAg positive and Hepatitis B Virus (HBV) DNA copy number positive (quantitative
detection =1000cps/ml), Hepatitis C Virus (HCV) antibody positive and HCV RNA
positive, or HIV positive.
8. History of autoimmune diseases (e.g, primary immunodeficiency, inflammatory bowel
disease. idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous
hemolytic anemia, rheumatoid arthritis, etc.).
9. The following diseases have not been resolved to CTCAE grade 0-1, 7 days before the
conditioning chemotherapy, including: dyspnea, diarrhea, acute or chronic
pancreatitis.
10. New York Heart Association (NYHA) class 3 or 4.
11. Symptoms and sign of cardiovascular diseases, e.g., cardiovascular ischemia,
arrhythmias, and heart failure.
12. Symptoms and signs of cerebrovascular accidents.
13. History of 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.
14. Current or expected need for long-term systemic corticosteroid therapy. Note: Topical
and inhaled corticosteroids in standard doses and physiologic replacement for subjects
with adrenal insufficiency are allowed. Doses of corticosteroids of greater than or
equal to 5 mg/day of prednisone or equivalent doses of other corticosteroids are not
allowed.
15. Subjects of both genders who are not willing to practice birth control from the time
of consent through 6 months after the completion.-
16. Subjects have experienced major surgery or severe trauma within 4 weeks before
enrollment or are expected to undergo major surgery during the study period.
17. Combined with graft versus host disease (GVHD).-
18. Women of child-bearing potential who are pregnant or breastfeeding at the screening.
Females who have undergone surgical sterilization or who have been postmenopausal for
at least 2 years are not considered to be of childbearing potential.
19. Patients with confirmed history of neurological or psychotic disorders, including
epilepsy, seizure, dementia.
20. Any other condition that, in the discretion of the investigator, will make subjects
exposed to unnecessary risks or not compliance to participation in this clinical
study.
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