Colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, esophageal adenocarcinoma, esophagogastric junction cancer, etc.
Conditions
Interventions
Sponsors
The First Bethune Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18-65 years; 2. Positive expression of the target detected by immunohistochemistry (IHC) in a laboratory accredited by the partner; 3. Pathologically confirmed gastrointestinal tumor; 4. Patients who are ineffective or relapsed after at least first- and second-line standard therapy, those who are intolerant to standard therapy or who voluntarily give up; 5. At least one extracranial measurable lesion according to RECIST1.1 or EORTC or PERCIST criteria; 6. Expected survival period >= 90 days; 7. The function of major organs is normal, that is, the following criteria are met: (1) ECOG performance status score of 0~1 or KPS score >70; (2) The blood routine examination standards meet: HB>=90g/L (no blood transfusion within 14 days), ANC>=1.5 x 10^9/L, PLT>=80 x 10^9/L, Alb >= 2.8g/dL, serum lipase and amylase 50 ml/min (Cockcroft-Gault formula); (4) Cardiac ejection fraction > 55%; 8. No bleeding disorders or coagulation disorders; 9. No allergy to developer; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and be willing to use an appropriate method of contraception during the experiment and 8 weeks after the last CART administration (women who have undergone sterilization or have been postmenopausal for at least 2 years can be considered infertile); 11. The patients voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors in the past; 2. The transduction efficiency of T cells is less than 5% or the expansion of T cells after culture is less than 2 times; 3. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 4. Patients with hypertension that cannot be well controlled by a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, the specific situation is judged by the investigator), suffering from myocardial ischemia or myocardial infarction of grade I or above, arrhythmia of grade I or above (including QT interval >= 440ms), or cardiac insufficiency; 5. Wounds or fractures in the chest or other parts that have not healed for a long time; 6. Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders; 7. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 8. Presence of a fungal, bacterial, viral or other infection that is uncontrollable or requires antibiotic treatment. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted after consultation with a medical monitor; 9. For subjects who have used chemotherapy in the past, according to the NCI-CTCAE 4.0 criteria, there is >= grade 2 hematological toxicity at the time of enrollment, or >= grade 3 non-hematological toxicity; 10. Known HIV history, or positive nucleic acid test for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive); 11. Presence of any indwelling catheters or drains (eg, bile drains or pleural/peritoneal/pericardial catheters). Allow the use of dedicated central venous catheters; 12. There is brain metastasis; 13. There is a history or disease of the CNS, such as seizure disorder, cerebral ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 14. There is a major immunodeficiency; 15. Have a history of severe hypersensitivity reactions to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna used during pretreatment, tocilizumab and anti-infective drugs for the prevention and treatment of CRS, etc.); 16. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 17. History of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that lead to end-organ damage or require systemic immunosuppressive/systemic disease-modifying drugs within the past 2 years; 18. Any disease that may interfere with the evaluation of the safety or efficacy of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Countries
China
Contacts
Public ContactCui Jiuwei
The First Bethune Hospital of Jilin University
Outcome results
None listed