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

Beijing Immunochina Medical Science & Technology

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Melanoma

Non-small Cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Treatments

Biological: AMT-116 CAR-T cells

Biological: AMT-253 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT05117138

MHSW016

Details and patient eligibility

About

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.

Enrollment

39 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.