Head and Neck Squamous Cell Carcinoma, Melanoma, Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALAMT-116 CAR-T cells
1. Classical 3+3 dose escalation will be applied to 9 subjects with moderate or far advanced non-small cell lung carcinoma (NSCLC) enrolled. 2. Classical 3+3 dose escalation will be applied to 9 subjects with moderate or far advanced head and neck Squamous Cell Carcinoma (HNSCC) enrolled.
BIOLOGICALAMT-253 CAR-T cells
1.The classic 3 + 3 dose escalation will be applied to 9 selected subjects with moderate or far advanced melanoma by intravenous drip. 2.3 \ 6 patients with intermediate and advanced melanoma will be injected intratumorally at a dose of ≤ 1 × 10\^8 cells. 3.3 \ 6 patients with operable advanced melanoma will be treated with postoperative adjuvant treatment at a dose of ≤ 1 × 10\^8 cells ≤ intravenous drip on Day 1 of each 42 days cycle (8 cycle maximum).
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 24 weeks |
| Overall Response Rate (ORR) | 24 weeks |
| One year recurrence rate | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS) | 24 weeks |
| Relapse Free Survival(RFS) | 24 weeks |
Countries
China
Outcome results
None listed