gastric cancer
Conditions
Interventions
Case series:(CLDN18.2+CD19) targeted Chimeric Antigen Receptor T Cells (CART) Therapy
Sponsors
The Fifth Hospital Affiliated to Zhongshan University
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 target expression> 1 + as determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; 3. Pathology confirmed gastric cancer; 4. Unable to operate or not suitable for surgery patients; 5.According to RECIST 1.1 version of the standard has at least one measles extracranial lesions; 6. Expected survival = 60 days; 7. The main organs function properly, that is, meet the following criteria: 1) ECOG physical status score is 0 ~ 1 or KPS score> 70; 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>0.7×10^9/L, LY% =15%, Alb= 2.8g/dL, serum lipase and amylase 50 ml / min (Cockcroft-Gault formula); 4) Cardiac ejection fraction> 55%; 8. Women of childbearing age have to undergo a pregnancy test (serum or urine) within 7 days prior to 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); 9. 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. With 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