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Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors

NCT06126406 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-13

No results posted yet for this study

Summary

This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

Conditions

Interventions

BIOLOGICAL

CEA-targeted CAR-T cells

Administration method: intravenous infusion Subjects will receive conditioning therapy by ludarabine and Cyclophosphamide before cell infusion.

BIOLOGICAL

CEA-targeted CAR-T cells

Administration method: intraperitoneal injection Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Sponsors & Collaborators

  • First Affiliated Hospital of Wannan Medical College

    collaborator OTHER

  • Chongqing Precision Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • lili Sheng, M.D · First Affiliated Hospital of Wannan Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2025-12-31
Completion
2026-12-31

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 NCT06126406 on ClinicalTrials.gov