Clinical trial · Interventional
A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)
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
NCT04513431CI-TRIAL-00046640CRCunknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Stage III Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CEA-CAR T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Colorectal cancer
- description
- Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.
- interventionNames
- Biological: Anti-CEA-CAR T
Primary outcomes (1)
- measure
- Adverse events that related to treatment
- timeFrame
- 4 weeks
- 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 outcomes (3)
- measure
- Survival time of Anti-CEA CAR T cells in vivo.
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.