Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors

Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors

This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.

Inclusion Criteria:

• Age 18-70 years old, both men and women, and the survival period is more than 6 months.
• At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
• Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
• The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
• Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
• Routine blood examination: white blood cell count (WBC) ≥ 3 × 10^9 / L, lymphocyte count (ly) ≥ 0.8 × 10^9 / L, hemoglobin (HB) ≥ 90g / L, platelet (PLT) ≥ 80 × 10^9/L.
• Liver and kidney function: alanine aminotransferase and aspartate aminotransferase < 3 ULN, total bilirubin (TBIL) < 1.5 ULN, serum creatinine (SCR) < 2 ULN.
• The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion Criteria:

• Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
• Patients with second tumor.
• Patients previously treated with car-t cells.
• Requiring long-term use of immunosuppressants for any reason.
• Any serious and 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.
• Subjects with severe heart, lung, liver and kidney dysfunction or severe lung diseases.
• Current systemic use of steroid cells (except for recent or current use of inhaled steroids).
• Pregnant and lactating subjects.
• Allergic to immunotherapy and related cells.
• Subjects with a history of organ transplantation or waiting for organ transplantation.
• After evaluation, the investigator considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.