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

NCT05396300 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chongqing Precision Biotech Co., Ltd

    collaborator INDUSTRY

  • Weijia Fang, MD

    lead OTHER

Principal Investigators

  • Weijia Fang, M.D · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396300 on ClinicalTrials.gov