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COMPLETED
NCT05396300
PHASE1

A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors

Sponsor: Weijia Fang, MD

View on ClinicalTrials.gov

Summary

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Official title: A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2022-05-25

Completion Date

2026-06-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Intraperitoneal infusion of FAST CEA-targeted CAR-T

Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.

BIOLOGICAL

CEA CAR-T cells

Administration method: intravenous infusion or intraperitoneal injection; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

BIOLOGICAL

CEA CAR-T cells

Administration method: intravenous infusion or intraperitoneal injection; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Locations (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China