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(Last updated: December 06, 2019)

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1

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for 4-5 weeks

PHASE: II

NCT ID: NCT04102436

Modified T Cell Immunotherapy (CAR-T)

A Phase II Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer Scientific Title

Purpose
To learn if a person's white blood cells modified with T-cell receptors can cause solid tumors to shrink.
Who is this for?
Women and men with metastatic breast cancer that did not respond to the first treatment received.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be in the hospital and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Before hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of cells</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay for receiving treatment (4-5 weeks):</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Modified white blood cells, by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and Fludarabine (Fludara®) by IV</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, once every 8 hours, for up to 10 doses</li> <li class="seamTextUnorderedListItem">Antibiotics</li> <li class="seamTextUnorderedListItem">Filgrastim, by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">After hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visits approximately 6 and 12 weeks after treatment, then every 3-6 months for 3 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cells can be modified in a lab to recognize certain changes in the tumor. </li> <li class="seamTextUnorderedListItem">To create the personalized T cells, your white blood cells will be collected and modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">These supercharged T cells will then be put into your body. This will be done in the hospital. </li> <li class="seamTextUnorderedListItem">This type of therapy is called CAR-T cell therapy. </li> <li class="seamTextUnorderedListItem">Before you receive the enhanced T cells, you will be treated with the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). This is to prepare your body to receive the enhanced T cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that enhances immune function and filgrastim, to reduce your risk of developing an infection. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04102436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers</a> </li></ul>
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