advanced colorectal cancer
Conditions
Interventions
Experimental group:CAR-T immune cell therapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. With pathologically confirmed colorectal cancer; 3. More than 50% of tumor lesions with GCC expression >= 1+ as assessed by immunohistochemistry (IHC); 4. Patients with inoperable colon cancer who have failed multiple lines of in advanced stages; 5. With at least one extracranial measurable lesion according to RECIST Version 1.1; 6. Expected survival of >=90 days; 7. The main organs function properly, that is, meet the following criteria: (1) The ECOG physical status score is 0-1 or KPS score>70; (2) Blood test should meet the following criteria: HB >=90g/L (no blood transfusion within 14 days); ANC >= 1.5 x 10^9/L; PLT >=80 x 10^9/L, lymphocyte (LY) >=0.5 x 10^9/L, LY% >= 15%, Alb >= 25g/L, serum lipase and amylase 40ml/min (Cockcroft-Gault formula); (4) Heart score >55%; 8. No bleeding disorders or coagulopathy; 9. No allergy to contrast agents; 10. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment and the result is negative, and they are willing to use appropriate methods of contraception either during the experiment and 8 weeks after the last dose of CART (subject to sterilization or menopause women who have been at least 2 years old can be considered as having no fertility); 11. Participants voluntarily joined the study, signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Treated with chimeric antigen receptor or other transgenic T; 2. Pregnant or lactating women; 3. Participated in other drug clinical trials within 4 weeks before the study begins; 4. Patients with hypertension who are not well controlled by a single antihypertensive medication (systolic >160mmHg, diastolic >100 mmHg), or with grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias (Including QT interval >=440ms) or cardiac insufficiency; 5. With long-term unhealed chest or other parts of the wound or fracture; 6. With history of abuse of psychotropic substances can not be abstinent or mental disorders; 7. Past and current, patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired pulmonary function; 8. With fungi, bacteria, viruses or other infections that can not be controlled or require antimicrobial treatment. If there is a response to active treatment, after consulting with a medical monitor, it is allowed to have simple urinary tract infection and uncomplicated bacterial pharyngitis; 9. For patients with previously used chemotherapy, hematologic toxicity >= 2 or non-hematologic toxicity >= 3 at enrollment according to NCI-CTCAE 5.0 criteria; 10. With HIV, Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) infection; 11. With any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural/peritoneal/pericardial catheters). Allow the use of a dedicated central venous catheter; 12. With brain metastases; 13. With CNS history or disease, such as seizure disease, cerebrovascular ischemia/hemorrhage,dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. With significant immunodeficiency; 15. With a history of severe hypersensitivity reactions to the major therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab and anti-infectives against CRS during pretreatment; 16. With a history of deep venous thrombosis or pulmonary embolism within 6 months of enrollment; 17. A history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause damage to the terminal organ or that require systemic immunosuppression/systemic disease modulation over the past two years; 18. Any disease that may interfere with the safety of the study treatment or assessment of efficacy; 19. Female subjects who are unwilling to take birth control from the signing of the consent form to 6 months after the completion of the cell infusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful expansion of CAR-T cells;Objective response rate; | — |
Countries
China
Contacts
Public ContactLiu Hu
Anhui Provincial Cancer Hospital
Outcome results
None listed