drugset
drugset / Trial / NCT07247396

CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases

NCT07247396 ↗

Phase 1 Recruiting 12 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University Chongqing Precision Biotech Co., Ltd · collab
NaSingle-groupOpen-labelTreatment

Summary

This single-arm, open-label, dose-escalation trial aims to evaluate the safety and efficacy of CEA-targeted CAR-T cells and to obtain their pharmacokinetic profile in patients with advanced colorectal cancer and peritoneal metastases after cytoreductive surgery; the recommended dose will then be derived from these data.

Timeline

Start
2025-11-03
Primary completion
2027-05-31
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CEA-targeted CAR-T cells Cell therapy 100000 cells/kg Intrathecal
Subject CEA-targeted CAR-T cells Cell therapy 300000 cells/kg Intrathecal
Subject CEA-targeted CAR-T cells Cell therapy 500000 cells/kg Intrathecal
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —

Indications

peritoneal carcinomatosis