advanced tumors
Conditions
Interventions
test group:CART cell
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The age is between 18 and 70 years old; 2. Immunohistochemical (IHC) detection of positive target expression in the laboratory approved by the sponsor; 3. Cytology or pathology confirmed as one of lung cancer, ovarian cancer, esophageal cancer, stomach cancer, pancreatic cancer, endometrial cancer, cervical cancer, breast thyroid cancer, colorectal cancer, prostate cancer; 4. At least one extracranial measurable lesion according to RECIST1.1 standard; 5. Estimated survival time >= 90 days; 6. The main organs function normally, that is, they meet the following standards: 1) ecog physical fitness score is 0~1 or KPS score > 70; 2) The standard of blood routine examination is as follows: HB = 90g/L (no blood transfusion in 14 days), ANC = 1.5x10 9/L, PLT = 80x10 9/L, Alb = 2.8g/dL, serum lipase and amylase 50 ml/min (Cockcroft-Gault formula); 4) Cardiac ejection fraction > 55%; 5) The levels of calcium, potassium and magnesium in serum are within the standard range; 7. No hemorrhagic disease or coagulation dysfunction; 8. No allergy to developer; 9. Women of childbearing age must have a pregnancy experiment (serum or urine) within 7 days before joining the group, and the result is negative, and they are willing to use appropriate methods for contraception during the experiment and 8 weeks after the last CART (women who have undergone sterilization or at least 2 years after menopause can be considered as infertile); 10. Subjects volunteered to join this study, signed informed consent form, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous history of other malignant tumors; 2. T cell transduction efficiency is less than 5% or T cell amplification is less than 2 times after culture; 3. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 4. Patients with hypertension who can't be well controlled by single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, the specific situation is judged by the researcher), suffering from grade I or above myocardial ischemia or infarction, grade I or above arrhythmia (including QT interval = 440ms) or cardiac insufficiency; 5. Long-term unhealed wounds or fractures in the chest or other parts; 6. Those who have a history of psychotropic substance abuse and can't quit or those who have a history of mental disorders; 7. Past and present patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 8. There are fungal, bacterial, viral or other infections that are uncontrollable or require antibiotic treatment. After consulting the medical inspector, simple urinary tract infection and uncomplicated bacterial pharyngitis are allowed; 9. For subjects who have used chemotherapy in the past, according to NCI-CTCAE 4.0 standard, there is =2 grade hematological toxicity or =3 grade non-hematological toxicity at the time of enrollment; 10. It is known that there is a history of HIV, or the nucleic acid test of hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) is positive; 11. There are any indwelling catheters or drainage tubes (e.g., bile drainage tubes or pleural/peritoneal/pericardial catheters). Allow the use of special central venous catheter (colostomy, percutaneous nephrostomy, indwelling Foley catheter for patients with intestinal cancer, the researchers will consider whether there is any influence); 12. There is brain metastasis; 13. There is a history or disease of CNS, such as seizure disease, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. There is a major immunodeficiency; 15. Have a history of severe hypersensitivity to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna used during pretreatment, and tocuzumab and anti-infective drugs for prevention and treatment of CRS, etc.); 16. There is a history of deep vein thrombosis or pulmonary embolism within 6 months before joining the group; 17. There has been a history of autoimmune diseases (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ damage or require systemic immunosuppressive/systemic disease regulating drugs in the past 2 years; 18. Any disease that may interfere with the safety or efficacy evaluation of research treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and objective response rate (complete response [CR] + partial response [PR]) of CAR-T targeted therapy in patients with advanced solid tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Incidence of adverse events and changes in clinically meaningful safety laboratory values;Cytokine levels in serum; | — |
Countries
China
Contacts
Public ContactZhangxiao chun
Affiliated Hospital of Qingdao University
Outcome results
None listed