Colorectal Cancer
Conditions
Interventions
Single Group Dose Escalation Assignment:CAR-T cells infusion
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. = 18 years old, = 75 years old, male or female; 2. In patients with liver metastasis of colorectal cancer, the primary focus of colorectal cancer was treated with radical surgery, and the liver metastasis was treated with R0 resection (R0 resection is required in combination with other organ metastasis). There was no imageable lesion or tumor residue (except for invisible or unmeasurable lesions) after surgery; 3. The patients with CEA expression in tumor tissues of primary and liver metastases were detected by immunohistochemistry (the positive rate of CEA was more than 50% by pathological examination); 4. Life expectancy = 6 months; 5. PS score 0-2, KPS score above 60; 6. Patients whose ctDNA MRD is still positive or re-positive after completion of adjuvant chemotherapy (including preoperative neoadjuvant chemotherapy); 7. The function of important organs is sufficient, such as NYHA cardiac function grade III or above, hemoglobin = 90g/L, hypoxia; Liver function: total bilirubin = 1.5 × ULN (total bilirubin = 3 during liver metastasis × ULN)ALT=2.5 × ULNAST=2.5 × ULN (ALT or/and AST = 5 during liver metastasis × ULN) Renal function: blood creatinine = 1.5 × ULN and creatinine clearance rate = 50 mL/min, only in blood creatinine = 1.5 × Creatinine clearance was calculated at ULN; Minimum lung function reserve is required (dyspnea is not higher than grade 1 and blood oxygen saturation is more than 91% without oxygen inhalation); 8. Enough mononuclear cells (PBMC) can be obtained through peripheral veins without contraindication of mononuclear surgery; 9. People of childbearing age have no family planning and take effective contraceptive measures within 1 year after cell infusion.
Exclusion criteria
Exclusion criteria: 1. Have a serious history of central nervous system diseases; 2. There are residual lesions or tumor remnants visible on imaging, or other tissues and organs can not be removed from tumor lesions; 3. There are serious non-malignant diseases including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases; 4. Previously received CAR-T or other gene-modified T cell therapy; 5. Have participated in other clinical studies within 30 days before screening or plan to participate in other clinical studies during the study period; 6. Patients with active hepatitis B B (HBV-DNA copy number>105 copies/ml), active hepatitis C (HCV-RNA copy number>ULN), HIV infection, and syphilis spirochete infection were screened; 7. There are uncontrollable systemic infectious diseases; 8. In addition to colorectal cancer and its metastasis, other multiple malignant tumors; 9. Chinese herbal medicine, systemic glucocorticoid or other immunosuppressive agents may be needed within 2 weeks before enrollment or during the trial, which can have a negative impact on the activity or quantity of lymphocytes; 10. Pregnancy and lactation; 11. People with severe gastroduodenal ulcer, severe ulcerative colitis and other severe intestinal inflammation; 12. Those with serious respiratory diseases; 13. Those who cannot provide enough white films for tumor pathology for NGS detection (it is estimated that at least 15 white films are required); 14. The investigator judged that there were other circumstances that were not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security (Incidence and severity of adverse events);Effectiveness (minimal residual disease);Efficacy (recurrence-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) indicators (Cmax and AUC); | — |
Countries
China
Contacts
Public ContactWei Zhang
Shanghai Changhai Hospital
Outcome results
None listed