Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CEA-targeted CAR-T cells · 4 trials · 12 indications
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Dose-limiting toxicity after CEA CAR-T cell infusion
The incidence of adverse events after CEA CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
The incidence of adverse events (TEAE) after treatment; Incidence of treatment-related adverse events; Adverse evens of Special Interest (AESI);
Incidence and number of dose-limiting toxicity (DLT) cases，Dose-limiting toxicity after CAR-T cell infusion
| Arm | Type | Description |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg |
| Intrapleural infusion of CEA-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg |
| Intraperitoneal infusion of CEA-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg |
| intraperitoneal injection of CEA-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg |
| Intravenous of CD70-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg |
| intraperitoneal injection of CD70-targeted CAR-T | EXPERIMENTAL | Infusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg |
| Name | Type | Description |
|---|---|---|
| CEA-targeted CAR-T cells | BIOLOGICAL | Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. |
Inclusion Criteria: 1. Age ≥ 18 years, no gender restriction; 2. Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, and cholangiocarcinoma; 3. Failu...
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