lung cancer
Conditions
Interventions
Case series:(MUC-1+CD19) CART cell therapy
Sponsors
The Fifth Hospital Affiliated to Zhongshan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 - 65 years old; 2. Target expression =1 + as determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; 3. Pathological diagnosis is lung cancer; 4. Patients with advanced non-small cell lung cancer who failed to receive standard first-line and second-line drugs 5. Patients diagnosed as non-small cell lung cancer must be tested for EGFR mutation and ALK translocation. If the aforementioned condition requires treatment with appropriate tyrosinase inhibitors, the patient will not respond 6. Four weeks before treatment, there was no treatment with traditional Chinese medicine; 7. Serum calcium, potassium and magnesium levels were within the standard range; 8. At least one extracranial measurable lesion according to RECIST 1.1 standard; 9. Chemotherapy, radiotherapy, molecular boot therapy and surgery were not performed in the first four weeks of the study and have recovered from the acute toxicity of previous treatments, with the exception of alopecia and peripheral neurotoxicity; 10. Expected survival of = 3 months; 11. The main organs function properly, that is, meet the following criteria: 1) The ECOG physical status score is 0-2; 2) Blood test should meet the following criteria: HB=90g/L (no blood transfusion within 14 days); ANC=1.5 ×10^9/L; PLT=80 ×10^9/L; 3) biochemical tests should meet the following criteria: TBIL=1.5 x ULN (upper limit of normal); ALT and AST=2.5 x ULN; ALT and AST=5xULN if liver metastases; serum Cr=1xULN, endogenous creatinine clearance > 50 ml / min (Cockcroft-Gault formula); 12. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment and the result is negative and are willing to use appropriate methods of contraception either during the experiment and 8 weeks after the last dose of CART (subject to sterilization or menopause Women who have been at least 2 years old can be considered as having no fertility); 13. Participants voluntarily joined the study, signed informed consent, good compliance with follow-up.
Exclusion criteria
Exclusion criteria: 1. T cell transduction efficiency 140 mmHg, diastolic> 90 mmHg), patients with grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias Including QT interval = 440ms) or complete cardiac function; 6. Long-term unhealed chest or other parts of the wound or fracture; 7. Those with history of abuse of psychotropic substances who can not be abstinent or who have mental disorders; 8. Past and current patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired pulmonary function; 9. There are fungi, bacteria, viruses or other infections that can not be controlled or require antimicrobial treatment. If there is a response to active therapy, a simple urinary tract infection and no complication of bacterial pharyngitis are allowed after consultation with the medical examiner; 10. For subjects with previously used chemotherapy, =2 hematologic toxicity or =3 non-hematologic toxicity at enrollment according to NCI-CTCAE 4.0 criteria; 11. A known history of HIV or Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) infection is known; 12. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural / peritoneal / pericardial catheters). Allow use of a dedicated central venous catheter; 13. brain metastases; 14. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 15. There is a significant immunodeficiency; 16. Have a history of severe hypersensitivity reactions to the major therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab and anti-infectives against CRS during pretreatment; 17. There was a history of deep venous thrombosis or pulmonary embolism within the first 6 months of enrollment; 18. A history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause damage to the terminal organ or that require systemic immunosuppression / systemic disease modulation over the past two years; 19. Any disease that may interfere with the safety of the study treatment or assessment of efficacy; 20. Female subjects who are unwilling to take birth control 6 months after signing CART since signing consent; 21. hemorrhagic disease or coagulation dysfunction; 22. allergy to photographic developer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET CT; | — |
Countries
China
Contacts
Public ContactPengfei Pang
The Fifth Hospital Affiliated to Zhongshan University
Outcome results
None listed