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RECRUITING
NCT06013111
PHASE1

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

Sponsor: China Medical University, China

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2023-10-23

Completion Date

2026-09-01

Last Updated

2024-02-21

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Intravenous infusion anti-CEA-CAR-T cell

Anti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10\^7 CAR-T cells/kg, 1×10\^7 CAR-T cells/kg, and 3×10\^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.

Locations (1)

The First Affiliated Hospital of China Medical Univeristy

Shenyang, Liaoning, China