Description:
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.
Title
- Brief Title: A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)
- Official Title: A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
RJBY_anti-CEA CAR-T_CRC01
- NCT ID:
NCT04513431
Conditions
- Stage III Colorectal Cancer
- Colorectal Cancer Liver Metastasis
Interventions
Drug | Synonyms | Arms |
---|
Anti-CEA-CAR T | | Colorectal cancer |
Purpose
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 studies in solid tumors. The carcino-embryonic antigen(CEA) is
widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast
cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we
have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective
killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive
gastric cancer. The primary goal is to confirm its adverse effects including cytokine storm
response and any other adverse effects. In addition, tumor targeting and disease status after
treatment will also be evaluated.
Trial Arms
Name | Type | Description | Interventions |
---|
Colorectal cancer | Experimental | Colorectal cancer treated with T cells modified with Anti-CEA-CAR T. | |
Eligibility Criteria
Inclusion Criteria:
1. CEA positive T4/N2 high-risk stage-Ⅲ colorectal cancer after surgery or patients with
colorectal cancer liver metastasis after R0 surgery;
2. Patients whose serum CEA ≥11 ng/mL;
3. Life expectancy ≥ 3 months;
4. PS score 0-2, KPS score ≥60;
5. >3 CTC/7.5 mL blood sample;
6. Patients who plan to use XELOX chemotherapy after surgery;
7. 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;
8. Sufficient peripheral blood can be obtained through peripheral veins without
contraindications to apheresis;
9. 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 Criteria:
1. Patients who have a history of severe central nervous system disease;
2. Other organ metastases except liver;
3. Patients who have non malignant diseases, including autoimmune diseases, primary
immunodeficiency diseases or obstructive or restrictive respiratory diseases;
4. Patients received car-t or other gene modified T cell therapy previously;
5. Patients who plan to use other targeted anti-tumor drugs;
6. Patients who participated in other clinical studies within 30 days before screening or
planned to participate in other clinical studies during the study period;
7. 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;
8. Patients who have uncontrollable systemic infectious diseases;
9. Patients who have multiple malignant tumor;
10. Patients who received or may need Chinese herbal medicine, systemic glucocorticoid or
other immunosuppressants within 2 weeks before enrollment;
11. Patient who are pregnancy and lactating;
12. Patients who have severe gastroduodenal ulcer, ulcerative colitis and other intestinal
inflammation;
Maximum Eligible Age: | 65 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse events that related to treatment |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) |
Secondary Outcome Measures
Measure: | Survival time of Anti-CEA CAR T cells in vivo. |
Time Frame: | 3 months |
Safety Issue: | |
Description: | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. |
Measure: | Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells |
Time Frame: | 6 months |
Safety Issue: | |
Description: | To evaluate the presence of circulating tumor cells with flow cytometry and real time PCR in patient blood. |
Measure: | Maximum tolerated dose (MTD) of CEA targeted CAR T cells |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | To confirm the maximum tolerated dose of CEA targeted CAR T cells. |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Ruijin Hospital |
Last Updated
August 14, 2020