Status:
UNKNOWN
A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
HuaDao (Shanghai) Biomedical Co., Ltd.
Conditions:
Stage III Colorectal Cancer
Colorectal Cancer Liver Metastasis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Detailed Description
Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has few...
Eligibility Criteria
Inclusion
- CEA positive T4/N2 high-risk stage-Ⅲ colorectal cancer after surgery or patients with colorectal cancer liver metastasis after R0 surgery;
- Patients whose serum CEA ≥11 ng/mL;
- Life expectancy ≥ 3 months;
- PS score 0-2, KPS score ≥60;
- \>3 CTC/7.5 mL blood sample;
- Patients who plan to use XELOX chemotherapy after surgery;
- Patients must have adequate organ function , such as NYHA heart function classification grade III or higher, no severe anemia, hypoxia; liver function: total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN when liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN when liver metastasis); renal function: blood creatinine ≤1.5 × ULN and creatinine clearance ≥50 mL/min, only when blood creatinine ≤ Calculate the creatinine clearance rate when 1.5 × ULN;
- Sufficient peripheral blood can be obtained through peripheral veins without contraindications to apheresis;
- Patients of childbearing age have no birth plans and take effective contraceptive measures during the study period and within 1 year after the study.
Exclusion
- Patients who have a history of severe central nervous system disease;
- Other organ metastases except liver;
- Patients who have non malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
- Patients received car-t or other gene modified T cell therapy previously;
- Patients who plan to use other targeted anti-tumor drugs;
- Patients who participated in other clinical studies within 30 days before screening or planned to participate in other clinical studies during the study period;
- Patients who have syphilis or HIV / HBV / HCV / HPV / EBV / CMV infection ; HBV-DNA copy number ≥ 1 × 10 \^ 5 copies / ml is required for HBV seropositive patients;
- Patients who have uncontrollable systemic infectious diseases;
- Patients who have multiple malignant tumor;
- Patients who received or may need Chinese herbal medicine, systemic glucocorticoid or other immunosuppressants within 2 weeks before enrollment;
- Patient who are pregnancy and lactating;
- Patients who have severe gastroduodenal ulcer, ulcerative colitis and other intestinal inflammation;
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04513431
Start Date
August 30 2020
End Date
August 30 2023
Last Update
August 14 2020
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