liver tumor
Conditions
Interventions
Sponsors
the Affiliated Drum Tower Hospital, School of Medicine, Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. GPC3 high expression hepatocellular carcinoma patients which can not be treated by liver resection; tumor size > 3. Aged 18 to 69 years; targeted therapy failed or was intolerant; 2. Pre-chemotheropy failed or was intolerant, predicted survival rate > 3 months; 3. Degree of liver cirrhosisclass A or class B 7 according to Child-puge grading standard; Routine blood testwhite blood cell count(WBC) =2.5×10^9/L, Platelet(PLT)>60 ×10^9/L, intermediate cell(MID)>1.0 ×10^9/L , Lymphocyte(LY)>0.4×10^9/L, Lymphocyte percentage(LY%)=15%hemoglobinHbo(Hb)=90g/L; 4. Liver and Pancreatic functionalbumin(ALB) =35g/L, serum lipase(LPS)90%( Room temperature); Ejection fraction(EF)>55%; 6. No hemorrhagic and coagulant dysfunction; 7. No contrast agent allergy; 8. contraception: contraception measures should be taken within the clinical trial and 3 months after the last cell transfusion; 9. Peripheral venous access no contraindication of lymphocyte separation; 10. Karnofsky functional status score >60%; informed consent.
Exclusion criteria
Exclusion criteria: 1. Efficicency of transfection in lymphocyte < 5% or CAR-positive T cell amplification < 5%; 2. CAR-positive T cell rate < 10 or T cell expansion rate < 5 response to aCD3/CD28 stimulation; 3. pregnant women or women in lactation; 4. during ongoing treatment using systemic steroid or steroid inhalants; 5. Study of the beginning (blood) 30 days before the study of the disease for chemotherapy, the use of targeted anti-tumor drugs or interventional therapy for cancer; 6. Study of the beginning (blood) four weeks before the study of the disease for radiotherapy; 7. Previously accept any cell therapies or any other biopharmaceutical; 8. Uncontrolled symptoms or diseases; 9. Patients suffering severe/acute anaphylaxis; 10. Patients undergoing other clinical trials; 11. History of liver transplantation; 12. Patients with unstable or active gastrointestinal or respiratory bleeding present or currently undergoing anticoagulation with drugs such as warfarin or heparin; 13. subjects with previous organ transplantation or ready for organ transplantation; 14. Study of the beginning (blood) 4 weeks before the study of the disease for chemotherapy, the use of targeted anti-tumor drugs or interventional therapy for cancer; 15. Other concomitant antineoplastic therapies; 16. The investigator assessed the requirement that the patient was unable or unwilling to comply with the study protocol; 17. Patients can treated by liver resection, liver transplantation, TACE or RFA; 18. with hepatic encephalopathy past or currently; 19. with Active virus, fungus, or bacterial infection; 20. NYHA Criteria(II-IV); 21. Previously intolerance of Cyclosporin or Fludarabine 22. the concomitant anti-tumor treatment. subjects judged by investigators as not appropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;cell pharmacokinetics;efficiency; | — |
Countries
China
Contacts
Public ContactBeicheng Sun
the Affiliated Drum Tower Hospital, School of Medicine, Nanjing University
Outcome results
None listed