drugset / Trial / 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
Phase 1
Recruiting
9 enrolled
China Medical University, China
Shanghai First Song Therapeutics Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Timeline
- Start
- 2023-10-23
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CEA-CAR-T cell | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | anti-CEA-CAR-T cell | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | anti-CEA-CAR-T cell | Cell therapy | 3e+07 cells/kg | Intravenous |