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History of Changes for Study: NCT02850536
CAR-T Hepatic Artery Infusions for CEA-Expressing Liver Metastases (HITM-SURE)
Latest version (submitted October 20, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 29, 2016 None (earliest Version on record)
2 November 15, 2016 Contacts/Locations, Study Status and Sponsor/Collaborators
3 February 2, 2017 Recruitment Status, Study Status, Oversight and Contacts/Locations
4 April 6, 2018 Study Status, Study Description, Study Identification and Outcome Measures
5 June 14, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
6 March 25, 2019 Study Status and Sponsor/Collaborators
7 March 10, 2020 Study Status
8 May 4, 2020 Study Status
9 October 29, 2020 Study Status
10 October 20, 2021 Recruitment Status and Study Status
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Study NCT02850536
Submitted Date:  July 29, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 350-74
Brief Title: CAR-T Hepatic Artery Infusions for CEA-Expressing Liver Metastases (HITM-SURE)
Official Title: Phase Ib Trial of CAR-T Hepatic Artery Infusions Delivered With the Surefire Infusion System (SIS) for CEA-Expressing Liver Metastases
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Not yet recruiting
Study Start: August 2016
Primary Completion: August 2017 [Anticipated]
Study Completion: August 2017 [Anticipated]
First Submitted: July 14, 2016
First Submitted that
Met QC Criteria:
July 29, 2016
First Posted: August 1, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 29, 2016
Last Update Posted: August 1, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Roger Williams Medical Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered via the hepatic artery using the Surefire Infusion System (SIS) for patients with CEA-expressing liver metastases.
Detailed Description: 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 percutaneous hepatic artery infusion at specific cell doses. Prior to the first dose, each patient will undergo diagnostic angiography to verify suitable arterial anatomy. Three anti-CEA CAR-T doses per patient are planned at 1-week intervals. Low dose interleukin-2 will be given via an ambulatory infusion pump for 4 weeks. Normal liver and tumor biopsies will be obtained at the time of the initial diagnostic angiogram and during the final session following the 3rd CAR-T infusion.
Open or close this module Conditions
Conditions: Liver Metastases
Keywords: Colorectal Cancer
Liver Metastases
Breast Cancer
Gastric Cancer
Pancreas Cancer
Carcinoembryonic antigen
CAR-T
Immunotherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 5 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: anti-CEA CAR-T cells
Three infusions of gene-modified anti-CEA T cells over the course of 3 weeks into the hepatic artery via a percutaneous approach along with low dose IL-2.
Biological: anti-CEA CAR-T cells
Gene modified patient T cells
Other Names:
  • Designer T cells
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety of CAR-T cell hepatic artery infusions delivered using the Surefire Infusion System (SIS) as Measured by Number of Participants with Adverse Events
[ Time Frame: 10 weeks ]

To determine the safety and regimen limiting toxicity (RLT) of anti-CEA CAR-T hepatic artery infusions (HAI) via the Surefire Infusion System (SIS) for CEA-expressing liver metastases
Secondary Outcome Measures:
1. Radiographic treatment response by MRI
[ Time Frame: 10 weeks ]

Changes in tumor size
2. Radiographic treatment response by PET
[ Time Frame: 10 weeks ]

Changes in tumor metabolic activity
3. CAR-T detection in liver tumors
[ Time Frame: 10 weeks ]

Quantification of CAR-T cells in liver tumor core biopsies
4. CAR-T detection in normal liver tissue
[ Time Frame: 10 weeks ]

Quantification of CAR-T cells in normal liver core biopsies
5. CAR-T detection in extrahepatic sites
[ Time Frame: 10 weeks ]

Quantification of CAR-T in blood samples
6. Serum Cytokine Levels
[ Time Frame: 10 weeks ]

Measurement of cytokines as indicators of immune response
7. CEA level
[ Time Frame: 10 weeks ]

Measurement of serum tumor marker (ng/ml)
8. Tumor biopsy
[ Time Frame: 10 weeks ]

Assessment of tumor necrosis and fibrosis
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Patient with histologically confirmed diagnosis of CEA+ adenocarcinoma and liver metastases. Patient must have either histologic confirmation of the liver metastases or histologic documentation of the primary tumor and definitive radiologic evidence of liver involvement. Measurable disease is required with lesions of > 1.0 cm by CT. Soluble CEA is not acceptable as the sole measure of disease. Limited extrahepatic disease is acceptable if confined to the lungs or peritoneal cavity.
  • Tumor must be CEA-expressing as demonstrated by elevated serum CEA levels (≥10ng/ml) or immunohistochemistry on a biopsy specimen. Archived tissue is acceptable for determination of CEA expression.
  • Patient must be at least 18 years of age.
  • Patient able to understand and sign informed consent.
  • Patient with a life expectancy of greater than four months.
  • Patient failed at least one line of standard systemic chemotherapy and has unresectable disease.
  • Patient with performance status of 0 to 1 (ECOG).
  • Patient with adequate organ function as defined in protocol.
  • Acceptable hepatic vascular anatomy as determined by CT, MR, or conventional angiography. A nuclear medicine study will be performed to document the absence of a significant hepatic-pulmonary shunt (<20%).

Exclusion Criteria:

  • 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.
  • Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded, as outlined in section 5.2.8.
  • Patients with active clinical disease caused by CMV, hepatitis B or C, HIV or tuberculosis will be excluded from the study.
  • Patients who have had cytotoxic and/or radiation therapy within 4 weeks prior to entry into the trial or 4 weeks prior to infusion will be excluded. Patients with other concurrent malignancies will be excluded.
  • Patients requiring systemic steroids will be excluded.
  • Patients with unsuitable hepatic vascular anatomy will be excluded from the study.
  • Patients with extrahepatic metastatic disease beyond the lungs or abdominal/ retroperitoneal lymph nodes.
  • Patients with >50% liver replacement at time of treatment will be excluded.
  • Previous external beam radiotherapy to the liver.
  • Portal vein thrombosis.
Open or close this module Contacts/Locations
Central Contact Person: Ashley Larkin, RN
Telephone: 401-456-2268
Email: ALarkin@chartercare.org
Study Officials: Steven Katz, MD
Principal Investigator
Roger Williams Medical Center
Locations: United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Contact:Contact: Ashley Larkin, RN 401-456-2268 ALarkin@chartercare.org
Contact:Principal Investigator: Steven Katz, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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