Recurrence or metastasis of colorectal cancer
Conditions
Interventions
Case series:Nucleosome Complex CAR-T cells
Sponsors
Affiliated Hospital of Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18 and 70 years old male and female; (2) Patients with primary colorectal cancer with clear histopathological diagnosis; (3) recurrence or metastasis after treatment; (4) According to RECIST 1.1, patients have tumor lesions that can be evaluated for efficacy; (5) Comprehensive physical condition ECOG score 0-2 points; (6) Expected survival time > June; (7) Serology: HIV antibody negative; hepatitis B surface antigen, e antigen negative; hepatitis C antibody negative; female patients with negative pregnancy test; blood routine: neutrophils more than = 1.5 × 10^9/L, WBC = 3.0 × 10^9/L, lymphocytes=0.8×10^9/L, platelets=70×10^9/L, hemoglobin=85g/L; blood biochemistry: serum albumin=30g/L; ALT, AST=2.5 times normal upper limit; for liver In patients with metastasis, ALT, AST = 5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum urea nitrogen and creatinine = 1.5 times the normal upper limit; serum total bilirubin 50%; (10) The patient has no radiotherapy and chemotherapy within 4 weeks.
Exclusion criteria
Exclusion criteria: (1) There are any autoimmune diseases; (2) Receive systemic hormone therapy or receive immunosuppressive therapy 4 weeks before enrollment; (3) There is active infection or unexplained fever during screening period >38.5 degree C (subject to the study, the subject may be enrolled due to fever generated by the tumor); (4) Participated in other clinical studies within the first three months of enrollment; (5) A history of severe allergies, allergic to T cell therapy products or other biological agents; (6) Patients who exclude brain metastases or have clinical symptoms of suspected brain metastases; (7) Pregnancy, planned pregnancy or lactation women; (8) The investigator's clinical judgment is not suitable for patients with severe systemic diseases in this study, including but not limited to severe liver function abnormalities, severe coagulopathy, and severe mental system diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor markers; | — |
Countries
China
Contacts
Public ContactZhongfa Xu
Affiliated Hospital of Shandong Academy of Medical Sciences
Outcome results
None listed