advanced malignant tumors
Conditions
Interventions
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who met the inclusion criteria included those with advanced malignancy who were enrolled and had no effective treatment options available, and male and female subjects with a limited prognosis (less than two years of survival) after currently available treatment interventions: 1. Patients with advanced malignant tumors aged 18-70 years, and there is no feasible and effective treatment; 2. Malignant tumor tissue samples were positive for mesothelin; 3. Have received at least the first-line chemotherapy regimen (there is no restriction on the specific chemotherapy regimen) and at least 4 weeks before the last chemotherapy session; 4. Study expected survival after first dose >12 weeks; 5. There is at least one target lesion that can be assessed by imaging (=10mm); 6. ECOG performance status score 0-1; 7. Have sufficient venous access for apheresis or venous blood collection, and there are no other hemolytic separation contraindications; 8. WBC=2.5×10^9/L, plt=100×10^9/L, HB=9.0g/dl, MID=1.5×10^9/L, LY=0.47×10^9/L; LY%=15%; 9. Serum Alb=30g/L; 10. Serum lipase and amylase 2.5ULN, AST and ALT<ULN; 13. Serum total bilirubin =1.5ULN; 14. PT: INR<1.7, PT<(ULN+4)s; All laboratory test results should be within the above-mentioned stable range and there is no continuous supportive treatment.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria cannot be selected for this study: 1. CAR positive T cells 300 mg/day; clopidogrel, measurement >75 mg/day); 13. Four weeks before the start of the study, radiochemotherapy or use of targeted antitumor drugs for the study of the disease; 14. Major surgery or significant trauma within the first 4 weeks of the study (blood sampling), or expected major surgery during the study; 15. Researchers evaluate that patients are unable or unwilling to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T lymphocyte subsets;meso-CAR-T cell;Tumor burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactShen Zan
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Outcome results
None listed