$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

2018-09-13

2020-12

2021-03

0

Study Overview

CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.

Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by intraperitoneal infusion at specific cell doses. One anti-CEA CAR-T dose per patient is planned. Additional cycles may be administered at the discretion of the principal investigator. Normal peritoneal and tumor biopsies will be obtained at the time of the CAR-T infusion, on the final day of the treatment period, and during reporting interval #3.

  • Peritoneal Carcinomatosis
  • Peritoneal Metastases
  • Colorectal Cancer
  • Gastric Cancer
  • Breast Cancer
  • Pancreas Cancer
  • Carcinoembryonic Antigen
  • BIOLOGICAL: anti-CEA CAR-T cells
  • 340-74

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

2018-09-21  

N/A  

2022-03-25  

2018-09-21  

N/A  

2022-04-06  

2018-09-25  

N/A  

2022-03  

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: anti-CEA CAR-T cells

One intraperitoneal infusion of gene-modified anti-CEA T cells are administered to patients with CEA-expressing peritoneal metastases or malignant ascites

BIOLOGICAL: anti-CEA CAR-T cells

  • Intraperitoneal delivery of anti-CEA CAR-T cells
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety of Intraperitoneal CAR-T Cell Infusions as Measured by Number of Participants with Adverse EventsTo determine the safety and maximum tolerated dose (MTD) following intraperitoneal infusion(s) of anti-CEA CAR-T cells for inoperable CEA+ peritoneal metastases or malignant ascites.16 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression-Free SurvivalAs a measure of activity, Progression-free survival (PFS) will be assessed. The events for the assessment of PFS are disease progression and death events20 weeks
Overall SurvivalAs a measure of activity, Overall Survival (OS) will be assessed. The events for the assessment of OS are death events.20 weeks
Bowel Obstruction Free SurvivalMeasuring the time frame in which a patient does not experience a bowel obstruction20 weeks
Changes in Quality of LifeChanges in quality of life measured by Quality of Life Index (IQI) survey pre and post-treatment20 weeks
Response by the Peritoneal Carcinomatosis Index (PCI)Direct visualization of tumor burden assessment by the PCI pre and post-treatment16 weeks
Radiographic treatment response by MRIChanges in tumor size20 weeks
Radiographic treatment response by PETChanges in tumor metabolic activity20 weeks
Serologic response ratesMeasurement of CEA and CA19-920 weeks

Contacts and Locations

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

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:
1

    Inclusion Criteria:
    1. Age ≥ 18 years. 2. Must have documented CEA+ carcinomatosis or malignant ascites as demonstrated by an elevated serum CEA level (≥ 10 ng/mL) or immunohistochemistry on a biopsy or cytologic specimen (archived tissue is acceptable), for determination of CEA expression. Primary tumor may be intact and limited liver and/or lung disease permitted. 3. Must have at least evaluable disease by physical examination, serum tumor markers, radiologic assessment, tumor markers, or laparoscopic visual assessment. 4. Have a life-expectancy ≥ 12 weeks and ECOG performance status ≤ 2. 5. May have low volume of liver metastases defined as < 50% replacement of the liver volume by metastatic disease, as long as all other eligibility criteria are satisfied. 6. Be willing and able to comply with the study schedule and all other protocol requirements.
    Exclusion Criteria:
    1. Female patients of childbearing age will be tested for pregnancy. Pregnant patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control. 2. Received an investigational study drug within 14 days of leukapheresis or 28 days before receiving first dose of study drug. Exceptions may be granted with medical monitor approval. 3. Received any approved anticancer medication within 14 days of leukapheresis or 14 days before receiving the first dose of study drug. Exceptions may be granted with medical monitor approval. 4. Have any unresolved toxicity > Grade 2 from previous anticancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve. 5. Have a history of histologically confirmed metastases outside the peritoneal cavity, lungs, or liver. 6. Have high volume lung or liver metastases, defined as >5 lung lesions greater than 1 cm in size or ≥ 50% replacement the liver volume by metastatic disease. 7. Received CAR-T, CAR-T cell line, CAR-NK, CAR-pNK, or CAR-NK cell line therapies. 8. Have any of the following laboratory results at Screening (Screening volumes must be independent of blood product treatment):
    1. Hemoglobin ≤ 8.0 g/dL 2. Platelet count < 50 × 109/L 3. Absolute neutrophil count (ANC) < 1.0 × 109/L 9. Untreated or ongoing intra-abdominal infection or bowel obstruction. 10. Have any of the following laboratory results at Screening, regardless of causality:
    1. Serum creatinine ≥ 3.0, or estimated creatinine clearance ≤ 30 mL/min and not dialysis dependent 2. Aspartate aminotransferase (AST) ≥ 4 × upper limit of normal (ULN) and total bilirubin ≥ 2.0 mg/dL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome). 11. Have human immunodeficiency virus (HIV) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia, or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBsAg positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test. 12. Are pregnant or breastfeeding. 13. Have active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection. 14. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study. 15. Has any condition, including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study. 16. Left ventricular ejection fraction (LVEF) < 40%

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Steven C Katz, MD, Roger Williams Medical Center

    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

    Treat yourself

    Let Us Take Care Of You

    BOOK AN APPOINTMENT ⟶
    footer logo

    About

    Events

    Fundraising

    Contact Us

    Facebook-f Instagram

    NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

    Copyright © 2025 – National Pancreatic Cancer Foundation | All Rights Reserved

    Make-A-Will Month

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