drugset / Trial / NCT05538195
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Timeline
- Start
- 2022-06-07
- Primary completion
- 2023-12-30
- Completion
- 2024-02-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CEA-targeted CAR-T cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CEA-targeted CAR-T cells | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | CEA-targeted CAR-T cells | Cell therapy | 1e+07 cells/kg | Intravenous |