Late colorectal cancer
Conditions
Interventions
Sponsors
Kunming Yan'an Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Tested positive for target GUCY2C expression in immunohistochemistry (IHC) in a laboratory approved by the research cooperative; 3. Pathology confirms colorectal cancer; 4. Patients who have failed or relapsed with at least second-line standard treatment or who have not tolerated or voluntarily abandoned from standardized treatment; 5. Has at least one ultracranial measurable lesion as per RECIST1.1 or EORTC or PERCIST standard; 6. Expects >= 90 days; 7. The main organs function normally, namely meeting the following standards: (1) ECOG physical status score is 0~1 or the KPS score > 70; (2) Blood routine inspection meet the standard: 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 of > 55%; 8. Has no hemorrhagic disease or coagulation dysfunction; 9. Not allergic to the developer; 10. Women of childbearing age must undergo pregnancy experiments (serum or urine) within 7 days before the group and are negative and are willing to adopt appropriate contraception during the experiment and 8 weeks of final GUCY2C CART (women receiving at least 2 years after sterilization or menopause can be identified as not fertile); 11. Subjects volunteered to join the study, signed informed consent, good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. T cell transduction efficiency was 140 mmHg, diastolic> 90 mmHg, judged by the investigator), myocardial ischemia or myocardial infarction above grade I, grade I and above (including QT interphase >= 440ms) or cardiac insufficiency; 4. A wound or fracture of a long unhealed chest or elsewhere; 5. With a history of psychiatric substance abuse and withdrawal or a history of psychiatric disorder; 6. Patients with previous and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impaired lung function, etc; 7. Has fungi, bacteria, viruses, or other infections that are uncontrollable or require antibiotic treatment.After consultation with medical supervisors, the presence of simple urinary tract infections and uncomplicated bacterial pharyngitis was allowed; 8. For subjects with previous chemotherapy, there was >= grade 2 haematological toxicity, or >= grade 3 nonhaematological toxicity, at enrollment according to NCI-CTCAE 5.0 criteria; 9. Known to have a history of HIV, or has tested positive for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) nucleic acid; 10. Has any indwelling catheter or drainage tube (e. g., bile drainage tube or pleural / peritoneal / pericardial catheter).A dedicated central venous catheter is allowed (ostomy is seen in patients with bowel cancer, percutaneous renal ostomy, Follien catheter, considered by the investigator); 11. Has a brain metastasis; 12. Has a history or disease of CNS, such as seizure disease, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involved in CNS; 13. Has a major immune deficiency; 14. Had a history of severe hypersensitivity to major therapeutic agents in this study (including fludarabine, cyclophosphamide, sodium mesil, and tobizumab and antiinfectious agents against CRS used during pretreatment); 15. A history of deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 16. Has a history of autoimmune diseases (e. g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ damage or require systemic immunosuppression / systemic disease regulatory drugs over the past 2 years; 17. Has any disease that may interfere with the assessment of the safety or efficacy of the study treatment. 18. Cholecystectomy, vascular involvement and other researchers considered high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and objective remission rate of CAR-T targeted therapy in patients with advanced urinary tract tumors (complete remission [CR] + partial remission [PR]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Overall survival;Incidence of adverse events and serious adverse events;Vital signs, physical examination, laboratory examination;The level of serum cytokines (IL-2, IL-6, TNF- a, IFN ?, etc.) and the incidence of CRS; | — |
Countries
China
Contacts
Public ContactZhang Peixian
Kunming Yan'an Hospital
Outcome results
None listed