NSCLC
Conditions
Interventions
Experimental group:Infusion of tumor-infiltrating T lymphocyte injection
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, male or female; 2. Patients diagnosed with NSCLC III.B-IV., including but not limited to patients with non-small cell lung cancer with malignant pleural effusion, and confirmed disease progression by imaging examination at or after the most recent treatment; 3. At least one measurable objective tumor lesion as defined by RECIST 1.1 criteria; 4. Tumor samples with a volume of about 1-1.5cm3 can be obtained by surgery, puncture or bronchoscopy for the preparation of autologous tumor-infiltrating lymphocytes, or malignant pleural effusion >=250ml can be collected for the preparation of autologous tumor-infiltrating lymphocytes; 5. Subjects with Eastern Cooperative Oncology Group (ECOG) score performance status of 0~2 points; 6. HGB at least >=70g/L, blood transfusion is available; 7. Liver and kidney function, cardiopulmonary function meet the following requirements: a) Creatinine 90%; c) Total bilirubin <=1.5×ULN; ALT and AST<=2.5×ULN; 8. Expected survival time greater than 3 months and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with untreated or symptomatic brain metastases; 2. Previous organ allogeneic transplantation or cell transfer therapy including lymphodepletion therapy; 3. Patients who are receiving steroid therapy; 4. Combined with severe infection or persistent infection that cannot be effectively controlled; 5. Combined with severe autoimmune disease or congenital immunodeficiency; 6. History of severe allergy to biological products (including antibiotics); 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA] quantification higher than the lower limit of detection of the analytical method or positive hepatitis C antibody [HCV-Ab], HCV-RNA higher than the lower detection limit of the analytical method); 8. Human immunodeficiency virus (HIV) infection or syphilis infection; 9. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the trial. Note: Severe infection: refers to sepsis or infection with uncontrolled infection, which can be enrolled after infection control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composition, phenotype, and function of TILs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Disease control rate;Objective remission rate;Duration of remission;1-year/2-year DFS;Quality of life;Performance status score of the Eastern Oncology Cooperative Group;Blood routine;Blood biochemical; | — |
Countries
China
Contacts
Public ContactJidong Zhao
The Fourth Hospital of Hebei Medical University
Outcome results
None listed