$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

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

2021-09-10

2024-09-15

2025-09-15

36

Study Overview

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

This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.

Carcinoembryonic antigen (CEA) is a classic tumor marker, which is positively expressed in a variety of digestive tract tumors. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of digestive tract cells. In the early clinical trials of CAR-T targeting CEA carried out by the technical partner, it was found that CAR-T cell preparations have a certain killing effect on CEA-positive tumor cells. At the same time, no serious CAR-T-related adverse events were found through dose-escalating infusion. In this study, through the optimization of the CAR structure and the improvement of the culture method, the killing ability and survival ability of the CAR-T cell preparation on tumor cells in vitro and in vivo were improved to further verify the safety and efficacy.

  • Colorectal Cancer
  • Esophageal Cancer
  • Stomach Cancer
  • Pancreatic Cancer
  • Metastatic Tumor
  • Recurrent Cancer
  • BIOLOGICAL: CEA CAR-T cells
  • PBC034

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-06-09  

N/A  

2024-01-02  

2022-06-09  

N/A  

2024-01-05  

2022-06-13  

N/A  

2023-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Intravenous of CEA-targeted CAR-T

Infusion of CEA-targeted CAR-T cells by dose of 1-10x107 copy/kg

BIOLOGICAL: CEA CAR-T cells

  • Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
EXPERIMENTAL: intraperitoneal injection of CEA-targeted CAR-T

Infusion of CEA-targeted CAR-T cells by dose of 1-10x107 copy/kg

BIOLOGICAL: CEA CAR-T cells

  • Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)28 days
Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]Dose-limiting toxicity after cell infusion28 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]Disease control rate: including CR, PR and SD3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]Changes in serum tumor markers：CEA、 CA199、 CA1253 months
AUCS of CEA-CAR-T cells [Cell dynamics]AUCS is defined as the area under the curve in 28 days and 90 days1 years
CMAX of CEA-CAR-T cells [Cell dynamics]CMAX is defined as the highest concentration of CEA-CAR-T cells expanded in peripheral blood1 years
TMAX of CEA-CAR-T cells[Cell dynamics]TMAX is defined as the time to reach the highest concentration1 years
Pharmacodynamics of CEA-CAR-T cells[Cell dynamics]The content of free CEA in peripheral blood at each time point measured by Chemiluminescence immunoassay1 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jingwang Bi, M.D

Phone Number: 13066029387

Email: jingwangbi@live.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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 and failing (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 patient's serum CEA should 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>2.0×109/L, neutrophils>0.8×109/L, lymphocytes cells>0.5×109/L, platelets>50×109/L, hemoglobin>90g/L; 2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram; 3. Renal function: serum creatinine≤2.0×ULN; 4. Liver function: ALT and AST ≤3.0×ULN (for those with liver tumor infiltration, it can be relaxed to≤5.0×ULN); 5. Total bilirubin≤2.0×ULN; 6. Oxygen saturation > 92% in non-oxygen state. 9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection; 10. Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception); 11. The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
    Exclusion Criteria:
    1. Previous CAR-T therapy or other gene-modified cell therapy； 2. CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion; 3. Participated in other clinical studies within 1 month before screening; 4. vaccinated with live attenuated vaccine within 4 weeks before screening; 5. 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); 6. Active infection or uncontrollable infection requiring systemic treatment; 7. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months; 8. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1; 9. 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; 3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration); 4. History of severe non-ischemic cardiomyopathy; 10. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy; 11. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin; 12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; 13. Women who are pregnant or breastfeeding; 14. Other investigators deem it unsuitable to participate in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Jingwang Bi, M.D, Shandong Second Provincial General Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate