Advanced non-small cell lung cancer (squamous cell carcinoma) , head and neck squamous cell carcinoma and melanoma
Conditions
Interventions
Low dose level:Infuse 2.0×10^6 CAR+ T Cells/kg
High dose level:Infuse 10.0×10^6 CAR+ T Cells/kg
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Ages 18-70 (both ends), both men and women, with a pre-survival period greater than 6 months; 2) At least one evaluable lesion, those who have failed previous multi-line treatment or have stable disease after treatment; 3) Pathologically confirmed melanoma patients, non-small cell lung cancer (squamous cell carcinoma), and head and neck squamous cell carcinoma patients; 4) The surgically excised pathological tissue can be used for immunohistochemical detection of target proteins (paraffin sections should be within six months), and the target protein positive expression (immunohistochemical staining ++ or +++) that meets the pathological diagnosis; 5) Adequate venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection; 6) Routine blood test: white blood cell count (WBC) =3 × 109 / L, lymphocyte count (LY) =0.8 × 109 / L, hemoglobin (Hb) =90g / L, platelet (PLT) =80 × 109 / L ; 7) Liver and kidney function: Alanine aminotransferase, aspartate aminotransferase (ALT, AST) <3 times normal, total bilirubin (TBIL) <1.5 times normal, serum creatinine (SCr) <normal Twice the value; 8) Subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) People with active hepatitis B or C virus, HIV infection, or other uncured active infections; 2) Patients with a second tumor; 2) Patients who have previously received CAR-T cell therapy, PD-1 antibody therapy, and PD-L1 antibody therapy; 3) the need for long-term use of immunosuppressive agents for any reason; 4) Any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and Temporal arteritis, etc.; 5) Severe heart, lung, liver, and kidney dysfunction subjects or severe lung diseases; heart function: according to the New York Heart Association (NYHA) standards are grade 3 or above; liver function: Child-Puge classification standard is grade C Or above; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; lung function: symptoms of severe respiratory failure involving other organs; brain function: abnormalities of the central nervous system or disturbance of consciousness; 6) Cells currently using systemic steroids (except those who have recently or currently use inhaled steroids); 7) Pregnant and lactating subjects (The safety of this therapy for unborn children is unclear. Female research participants with reproductive potential must have a negative serum or urine pregnancy test within 48 hours before injection); 8) Allergic to immunotherapy and related cells; 9) Subjects with a history of organ transplantation or waiting for organ transplantation; 10) The investigator concluded that the subject was unable or unwilling to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity ; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed