drugset / Trial / NCT06006390
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
Phase 1/2
Recruiting
60 enrolled
Chongqing Precision Biotech Co., Ltd
Shanxi Bethune Hospital · collab
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
- 2023-09-07
- Primary completion
- 2025-12-31
- Completion
- 2026-08-31
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 | 1e+07 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |