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Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer

NCT00673829 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-06-17

No results posted yet for this study

Summary

The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with breast cancer. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (CEA). These modified cells are then given back to the participant so that they can attack and kill tumor cells.

Conditions

Interventions

BIOLOGICAL

Gene Modified T Cells

Gene Modified T Cells Phase Ia: One time infusion Modified TCells given through a vein in the arm or a catheter over a 30-60 minute period

BIOLOGICAL

Gene Modified T Cells and Interleukin 2

One time infusion Modified T Cells without or with (randomized) continuous infusion outpatient interleukin 2 (IL2) for two weeks

Sponsors & Collaborators

  • Roger Williams Medical Center

    lead OTHER

Principal Investigators

  • Richard P Junghans, PhD, MD · Roger Williams Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00673829 on ClinicalTrials.gov