Advanced lung cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The age is between 18 and 65 years old; 2. The expression of MSLN, the target of immunohistochemistry (IHC) in the laboratory approved by the sponsor, is positive; 3. Lung cancer confirmed by cytology or pathology in the indications of this test protocol; 4. Patients who have failed or relapsed after at least first-and second-line standard treatment, or patients who are intolerant or voluntarily give up for first-and second-line standard treatment; 5. At least one extracranial measurable lesion according to RECIST1.1 standard; 6. Estimated survival time >=90 days; 7. The main organs function normally, that is, they meet the following standards: (1) ECOG physical fitness score is 0~1 or KPS score > 70; (2) The standard of blood routine examination is as follows: HB (hemoglobin) >= 90g/L (no blood transfusion in 14 days), ANC (absolute value of neutrophils) >= 1.5*10^9/L, PLT (platelet) >= 80*10^9/L, Alb (albumin) >= 2.8g/dL, serum lipase and (3) Biochemical examination should meet the following standards: TBIL (total bilirubin) 50 ml/min (Cockcroft-Gault formula); (4) Cardiac ejection fraction > 55%; (5) The levels of calcium, potassium, and magnesium in serum are within the standard range; 8. No hemorrhagic disease or coagulation dysfunction; 9. No allergy to developer; 10. Women of childbearing age must have a pregnancy experiment (serum or urine) within 7 days before joining the group, and the result is negative, and they are willing to use appropriate methods for contraception during the experiment and 8 weeks after the last CAR-T (women who have undergone sterilization or at least 2 years after menopause can be considered as infertile); 11. Subjects volunteered to join this study, signed an informed consent form, complied well, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous history of other malignant tumors; 2. T cell transduction efficiency is less than 5% or T cell amplification is less than 2 times after culture; 3. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 4. Patients with hypertension who can't be well controlled by single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, the specific situation is judged by the researcher), suffering from grade I or above myocardial ischemia or infarction, grade I or above arrhythmia (including QT interval >= 440ms) or cardiac insufficiency; 5. Long-term unhealed wounds or fractures in the chest or other parts; 6. Those who have a history of psychotropic substance abuse and can't quit or those who have a history of mental disorders; 7. Past and present patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 8. There are fungal, bacterial, viral or other infections that are uncontrollable or require antibiotic treatment. After consulting the medical inspector, simple urinary tract infection and uncomplicated bacterial pharyngitis are allowed; 9. For subjects who have used chemotherapy in the past, according to NCI-CTCAE 4.0 standard, there is >=2 grade hematological toxicity or >=3 grade non-hematological toxicity at the time of enrollment; 10. It is known that there is a history of HIV, or the nucleic acid test of hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) is positive, and the specific and nonspecific antibodies of syphilis are positive; 11. There are any indwelling catheters or drainage tubes (e.g., bile drainage tubes or pleural/peritoneal/pericardial catheters). Allow the use of special central venous catheter (colostomy, percutaneous nephrostomy, indwelling Foley catheter for patients with intestinal cancer, the researchers will consider whether there is any influence); 12. There is brain metastasis; 13. There is a history or disease of CNS, such as seizure disease, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. There is a major immunodeficiency; 15. Have a history of severe hypersensitivity to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna used during pretreatment, and tocuzumab and anti-infective drugs for prevention and treatment of CRS, etc.); 16. There is a history of deep vein thrombosis or pulmonary embolism within 6 months before joining the group; 17. There has been a history of autoimmune diseases (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ damage (e.g. liver and kidney) or require systemic immunosuppressive/systemic disease regulating drugs in the past 2 years; 18. Any disease that may interfere with the safety or efficacy evaluation of research treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (complete response [CR]+ partial response [PR]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLiu Jing, Liu Jiwei
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed