Malignant head and neck squamous cell carcinoma
Conditions
Interventions
High dose level: 1.0×10^6 UCAR+ T Cells/kg
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) 18-70 years old, both males and females, the pre-survival period is greater than 4 months; 2) There is at least one assessable lesion, and the previous multi-line treatment has failed; 3) Patients with stage III/IV malignant head and neck squamous cell carcinoma confirmed by previous biopsy or histopathology; 4) The surgically resected pathological tissue can be used for immunohistochemical detection of the target protein, and the tumor marker AMT-116, which is in line with the pathological diagnosis, is stained strongly (++ or +++) positive; 5) For patients who are taking dexamethasone, the dosage must not be higher than 4mg/day 5 days before UCAR-T cell preparation for venous blood collection; 6) Sufficient venous access for blood drawing and venous blood sampling, no contraindications for lymphocyte collection; 7) Routine blood test: white blood cell count (WBC)>=3x10^9/L, lymphocyte count (LY) >= 0.8 x 10^9/L, hemoglobin (Hb) >= 110g/L, platelet (PLT) >= 60 x 10^9/L 8) Liver and kidney functions: alanine aminotransferase, aspartate aminotransferase (ALT, AST) <3 times the normal value, total bilirubin (TBIL) < 1.5 times the normal value, serum creatinine (SCr) < normal 2 times the value; 9) The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1) Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer test >= 3 x 10^2 copies/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA test positive; syphilis test positive; 2) Patients who have received any gene therapy before; 3) Long-term use of immunosuppressive agents is required for any reason; 4) Any serious, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohns disease and Temporal arteritis, etc.; 5) Subjects with severe heart, lung, liver, and kidney insufficiency or severe debilitating lung disease; heart function: grade 3 or above according to the New York Heart Association (NYHA) standard; liver function: Child-Puge grading standard Grade C or above; Renal function: Chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage III or above; Pulmonary function: severe respiratory failure symptoms involving other organs; Brain function: Central nervous system abnormalities or impaired consciousness; 6) Currently using steroids systemically (except for those who are using inhaled steroids recently or currently); 7) Pregnancy and lactation subjects (the safety of this therapy for unborn children is unclear. Female research participants with reproductive potential must have negative serum or urine pregnancy tests within 48 hours before injection ); 8) Allergic to immunotherapy and related drugs; 9) Subjects who have a history of organ transplantation or are waiting for organ transplantation; 10) After evaluation, the investigator believes that the subject is unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactFeng Lei
Outcome results
None listed