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CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases

NCT02416466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-03-26

No results posted yet for this study

Summary

This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.

Conditions

  • Liver Metastases

Interventions

BIOLOGICAL

anti-CEA CAR-T cells

Gene modified patient T cells.

DEVICE

Sir-Spheres

SIR-Spheres microspheres are a medical device used in Selective Internal Radiation Therapy (SIRT) for liver tumors. SIR-Spheres microspheres are a permanent implant and for single use only. The biocompatible resin microspheres containing yttrium-90 have a median diameter of 32.5 microns (range between 20 and 60 microns).

Sponsors & Collaborators

  • Sirtex Medical

    collaborator INDUSTRY

  • Roger Williams Medical Center

    lead OTHER

Principal Investigators

  • Steven C Katz, MD · Roger Williams Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-11-21
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02416466 on ClinicalTrials.gov