Relapsed/metastatic nasopharyngeal carcinoma
Conditions
Interventions
A dose group:3x10^6/CAR-T cells/kg:intravenous infusion
B dose group:9x10^6/CAR-T cells/kg:intravenous infusion
C dose group:1.5x10^7/CAR-T cells/kg:intravenous infusion
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Nasopharyngeal carcinoma was confirmed by pathological examination. 2. Be able to understand this study and have signed informed consent. 3. Age >=18 years old, =3 months. 5. The physical fitness score of the eastern tumor cooperation group (ECOG) was 0-1. 6. In situ hybridization (ISH or FISH) was detected positive for EBER in tumor tissue. 7. Immunohistochemical (IHC) detection of tumor tissue samples showed positive targets (>=20%). 8. Have at least one measurable lesion according to RECIST v1.1 criteria. 9. Subjects must have received adequate and failed systemic treatment as recommended by local nasopharyngeal cancer guidelines, including: 1) receiving at least one platinum-containing drug (cisplatin or carboplatin), monotherapy or combination therapy; 2) Subjects eligible for anti-PD-1 /L1 drugs had received at least one monotherapy or combination regimen containing anti-PD-1 /L1 drugs. 10. ntravenous access can be established for apheresis without contraindications for blood cell isolation. 11. Has adequate organ and bone marrow function, defined as: blood routine neutrophils (NEu #) >=1.0x10^9/L Platelets (PLT) >=80x10^9/L hemoglobin >=90g/L Liver function: No liver metastasis aspartate aminotransferase (AST) = 50 mL/min International Standardized Ratio of coagulation (INR) <=1.5xULN activated partial thrombin time (APTT) <=1.5xULN 12. Subjects (male or female) with reproductive potential must use effective medical contraception during the study period and for 6 months after the end of dosing. For female subjects of reproductive age, a pregnancy test must be performed no later than 72 hours prior to cell infusion and the result is negative.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to any of the drugs used in this study. 2. Previous antitumor therapy, including other investigational antitumor drugs, chemotherapy, immunotherapy, biologics, hormone therapy, radiotherapy (except local analgesic radiotherapy), etc., has not returned to baseline treaty-related toxicity or CTCAE=50% of total liver volume). 6. Clinically active infections (except simple urinary tract infections and bacterial pharyngitis) or intravenous antibiotics currently or within 14 days prior to enrollment (excluding prophylactic antibiotics, antiviral drugs and antifungal drugs). 7. HBsAg positive, HBV DNA copy number positive (quantitative detection >=1000cps/ml), HCV antibody positive, HCV RNA positive, or HIV positive test. 8. History of autoimmune diseases (such as primary immune deficiency, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autohemolytic anemia, rheumatoid arthritis, etc.) 9. The following diseases were CTCAE grade 0-1 that did not resolve within 7 days prior to treatment, including: dyspnea, diarrhea, acute or chronic pancreatitis. 10. NYHA cardiac function Score 3 or 4. 11. Signs and symptoms of cardiovascular disease, such as cardiovascular ischemia, arrhythmias, and heart failure. 12. Symptoms and signs of cerebrovascular accidents. 13. In addition to cervical carcinoma in situ or basal cell carcinoma of the skin and other malignancies with a disease-free survival of more than 5 years, there is a history of other non-nasopharyngeal carcinoma malignancies that cannot be cured within 3 years. 14. Long-term systemic glucocorticoid therapy is currently or expected to be required. Standard doses of topical and inhaled corticosteroids are permitted as physiological replacements for patients with adrenal insufficiency. Prednisone =5mg/ day or equivalent doses of other glucocorticoids are not permitted. 15. Male and female subjects who did not wish to use contraception from the date of signing the informed consent to 6 months after completion of BRG01 injection infusion. 16. subjects had undergone major surgery or severe trauma within the first 4 weeks of enrollment, or were expected to require major surgical intervention (i.e., surgery requiring the assistance of endotracheal anesthesia) during the study period. 17. With graft-versus-host disease (GVHD). 18. Fertile potential women who were pregnant or breastfeeding at the time of screening (women who had undergone sterilization or were at least 2 years post-menopausal were not considered fertile). 19. Patients with a history of central nervous system disease or psychosis. 20 Any other conditions that the investigator considers would cause the subject to be subject to unnecessary risk, or that the subject would be unable to comply with the study schedule and would therefore be unfit to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerated dose ;Adverse events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective To investigate the proliferation and survival of BRG01 injection in vivo;Objective response rate;Disease Control Rate;Duration of Response;Progression-free survival;Plasma EBV DNA content in relation to safety and efficacy;Incidence of serum anti-BRG01 anti-drug antibodies, correlation with PK, safety, and efficacy; | — |
Countries
China
Contacts
Public ContactLi Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed