NCT02850536

Brief Summary

This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered via the hepatic artery or splenic vein using the Surefire Infusion System (SIS) for patients with CEA-expressing liver metastases or pancreas cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

July 14, 2016

Last Update Submit

October 20, 2021

Conditions

Liver Metastases

Keywords

Colorectal CancerLiver MetastasesBreast CancerGastric CancerPancreas CancerCarcinoembryonic antigenCAR-TImmunotherapy

Outcome Measures

Primary Outcomes (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

    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

    10 weeks

Secondary Outcomes (9)

  • Radiographic treatment response by MRI

    10 weeks

  • Radiographic treatment response by PET

    10 weeks

  • CAR-T detection in liver tumors

    10 weeks

  • CAR-T detection in normal liver tissue

    10 weeks

  • CAR-T detection in extrahepatic sites

    10 weeks

  • +4 more secondary outcomes

Study Arms (1)

anti-CEA CAR-T cells

EXPERIMENTAL

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

Interventions

anti-CEA CAR-T cellsBIOLOGICAL

Gene modified patient T cells

Also known as: Designer T cells
anti-CEA CAR-T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

  • Katz SC, Moody AE, Guha P, Hardaway JC, Prince E, LaPorte J, Stancu M, Slansky JE, Jordan KR, Schulick RD, Knight R, Saied A, Armenio V, Junghans RP. HITM-SURE: Hepatic immunotherapy for metastases phase Ib anti-CEA CAR-T study utilizing pressure enabled drug delivery. J Immunother Cancer. 2020 Aug;8(2):e001097. doi: 10.1136/jitc-2020-001097.

    PMID: 32843493DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsStomach NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Steven C. Katz, MD

    Roger Williams Medical Center

    PRINCIPAL INVESTIGATOR

  • Richard Schulick, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

August 1, 2016

Study Start

February 1, 2017

Primary Completion

December 31, 2018

Study Completion

September 17, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

US(2)