Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06013111 | An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors | PHASE1 | RECRUITING | 9 | — | — | Oct 23, 2023 | Sep 1, 2026 | Feb 21, 2024 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Anti-CEA-CAR-T cell infusion | EXPERIMENTAL | Anti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10\^7 CAR-T cells/kg, 1×10\^7 CAR-T cells/kg, and 3×10\^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.The patients will receive lymphocyte clearance therapy with cyclophosphamide and fludarabine before the infusion. |
| Name | Type | Description |
|---|---|---|
| Intravenous infusion anti-CEA-CAR-T cell | BIOLOGICAL | Anti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10\^7 CAR-T cells/kg, 1×10\^7 CAR-T cells/kg, and 3×10\^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells. |
Inclusion Criteria: 1. Patients should understand and sign informed consent forms and voluntarily participate in clinical studies; 2. Age≥ 18, \< 70 years old, gender is not limited; 3. Locally advanced and/or metastatic solid tumors; Cytoplasmic and/or membranous high CEA expression in tumor tissu...