advanced solid tumors
Conditions
Interventions
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 75 years old. (2) Pathologically confirmed patients with solid tumors (such as patients with advanced gastric cancer and ovarian cancer) who have undergone standard second-line treatment such as surgery, radiotherapy, chemotherapy, or targeted therapy and or above; (3) The histopathological results of the patient's tumor are antigen expression, such as mesothelin>=15% or Claudin18.2 >=15%; (4) The patient has at least one tumor and can be accurately measured at baseline. The longest diameter at baseline >=10mm (if it is a lymph node, the short diameter is required to be greater than or equal to 15mm); (5) ECOG score 0~2, minimum expected survival is 12 weeks; (6) Have enough venous access for apheresis or venous blood collection; (7) Women of childbearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study treatment. Before starting the administration, the pregnancy test was negative, or there was no risk of pregnancy; (8) Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment; (9) The patient himself participated voluntarily and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. HIV positive, HBV and HCV positive, syphilis positive; 3. Spinal cord compression or brain metastasis, unless asymptomatic, stable disease, and steroid therapy is not required at least 2 weeks before the first administration of the study treatment; 4. Poorly controlled high blood pressure, active bleeding constitution or active infection; 5. Meet the following cardiac examination results: (1) Complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block, and PR interval>250 msec; (2) Left ventricular ejection fraction (LVEF) 100 U/L, aspartate aminotransferase (AST)>100 U/L; e. Creatinine>200umolL; (5) Total bilirubin>30µmolL; 9. Patients need long-term antiplatelet therapy (aspirin, dose>300mggday; clopidogrel, dose>75mggday); 10. Within two weeks before the start of the study, radiotherapy and chemotherapy for the study disease or targeted anti-tumor drugs were used; 11. Major surgery or significant trauma occurred within two weeks before the start of the study (blood sampling), or major surgery is expected during the study period; 12. Have a history of mental illness; 13. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAR-T cell; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactPeihua Lu
Wuxi People's Hospital
Outcome results
None listed