Metastatic lung cancer
Conditions
Interventions
Case series:MUC1 CART
Sponsors
Henan Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Between the ages of 18-65 years; 2. ST glycosylated MUC-1 expression> 1 + as determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; Pathology confirmed lung cancer; 4. Have received at least one standard treatment or after first-line, second-line treatment fails, again appear refractory, recurrent lung cancer, surgery or not suitable for surgery in patients without liver and lymph node metastasis; 5. Patients diagnosed with non-small cell lung cancer must be tested for EGFR mutations and ALK translocations, if any of the previously mentioned conditions require treatment ineffective with appropriate tyrosinase inhibitors; 6. 4 weeks before treatment did not carry out traditional Chinese medicine treatment; 7. Serum calcium, potassium and magnesium levels in the standard range; 8. According to RECIST 1.1 version of the standard has at least one extracepular measurable lesions can be measured lesions have not received radiotherapy; 9. Chemotherapy, radiotherapy, molecular boot therapy and surgery were not received within 4 weeks prior to study start-up and have been rescued from acute toxic reactions previously treated except for hair loss and peripheral neurotoxicity; 10. Expected survival = 3 months; 11. Asymptomatic brain metastases, or brain metastases that have undergone topical (surgery / radiotherapy) therapy prior to study initiation, are clinically stable for at least 8 weeks; 12. The main organs function properly, that is, meet the following criteria: 1) ECOG physical status score is 0 ~ 1 or KPS score> 60; 2) The blood test was consistent with the following criteria: HB=90g/L (no blood transfusion within 14 days), ANC=1.5×10^9/L, PLT=80×10^9/L, lymphocyte/L, LY% =15%, Alb =2.8g/dL, serum lipase and amylase 50 ml / min (Cockcroft-Gault formula); 4) Cardiac ejection fraction> 55%; 13. No hemorrhagic disease or coagulation disorders; 14. Does not cause allergic to the developer; 15. Women of childbearing age must undergo 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 (who have undergone sterilization or menopause Women who have been at least 2 years old can be considered as having no fertility); 16. Participants voluntarily joined the study, signed informed consent, compliance is good, 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 metastasis or uncontrollable 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 was a history of myocardial infarction, angioplasty or stenting, unstable angina or other clinically significant heart disease within the 12-month period, New York Heart Association (NYHA) class III or IV heart failure ; 16. There is a significant immunodeficiency; 17. 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 for CRS during the pretreatment; 18. The group had a history of deep venous thrombosis or pulmonary embolism within 6 months; 19. Any woman who has fertility during pregnancy or who is breast-feeding (women who have undergone sterilization or who have been at least 2 years after menopause may not be considered fertile); 20. A history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause damage to the terminal organ or which require systemic immunosuppression / systemic disease modulation over the past two years; 21. Any disease that may interfere with the safety of the study treatment or assessment of efficacy; 22. Female subjects who are unwilling to take birth control 6 months after signing the consent form and from completing the CART administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| petCT; | — |
Countries
China
Contacts
Public ContactQuanli Gao
He'nan Provincial Tumor Hospital
Outcome results
None listed