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Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors

A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy forCEA-positive Advanced/Metastatic Malignant Solid Tumors

NCT06010862•Chongqing Precision Biotech Co., Ltd

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/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Detailed Description

This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CEA-positive advanced/metastatic solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years old, male or female;
•2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
•3. After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
•4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.
•5. At least one assessable lesion according to RECIST 1.1 criteria;
•6. ECOG score 0-2 points;
•7. No serious mental disorder;
•8. Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:
•1. Blood routine: white blood cells\>3.0×10\^9/L, neutrophils\>0.8×10\^9/L, lymphocytes cells\>0.5×10\^9/L, platelets\>75×10\^9/L, hemoglobin\>80g/L;
•2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
+7 more criteria

Exclusion Criteria

•1. Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;
•2. Participated in other clinical studies within 1 month before screening;
•3. vaccinated with live attenuated vaccine within 4 weeks before screening;
•4. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
•5. Active infection or uncontrollable infection requiring systemic treatment;
•6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
•7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
•8. Suffering from any of the following heart diseases:
•1. New York Heart Association (NYHA) stage III or IV congestive heart failure;
•2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
+7 more criteria

Locations (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

September 30, 2023

Primary Completion Date

December 31, 2025

Completion Date

September 30, 2026

Last Updated

November 8, 2023

Enrollment

ESTIMATED participants

Conditions

Gastric CancerColon CancerPancreas CancerEsophagus CancerCholangiocarcinomaLung CancerBreast Cancer

Interventions

CEA CAR-T cells

BIOLOGICAL

CEA CAR-T cells

BIOLOGICAL

Contacts

Fei Li, M.D

CONTACT

13970038386 691058841@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors

Inclusion Criteria

Exclusion Criteria

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