Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Phase 1
- Conditions
- Non-small Cell Lung CancerHead and Neck Squamous Cell CarcinomaMelanoma
- Interventions
- Biological: AMT-116 CAR-T cellsBiological: AMT-253 CAR-T cells
- Registration Number
- NCT05117138
- Lead Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 39
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NSCLC/HNSCC：AMT-116 CAR-T cells AMT-116 CAR-T cells Patients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma. MEL：AMT-253 CAR-T cells AMT-253 CAR-T cells Patients with moderate or far advanced melanoma.
- Primary Outcome Measures
Name Time Method Incidence of adverse events 24 weeks Overall Response Rate (ORR) 24 weeks One year recurrence rate 24 weeks
- Secondary Outcome Measures
Name Time Method Progression-Free Survival(PFS) 24 weeks Relapse Free Survival(RFS) 24 weeks
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Beijing, Beijing, China