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NEAREST SITE: 2376 miles
University of Virginia
Charlottesville,VA

VISITS: At least 11 visits over 3-4 months; may require hospitalization

PHASE: I

NCT ID: NCT03661424

T-Cell Immunotherapy for Women with Breast Cancer-Related Leptomeningeal Metastases

A Phase I Study of Anti-CD3 x Anti-Her2/Neu (Her2Bi) Armed Activated T Cells (ATC) in Patients With Breast Cancer Leptomeningeal Metastases Scientific Title

Purpose
To study the safety and effects (good and bad) of an immunotherapy made from T-cells taken from your body that have been treated to go after cancer cells.
Who is this for?
Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer with leptomeningeal metastases (defined below).    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp, 2 weeks after the blood draw</li> <li class="seamTextUnorderedListItem">Methotrexate, by IV, at least once</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, weekly, for 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 brain MRIs (before the first and after the eighth infusion)</li> <li class="seamTextUnorderedListItem">Blood draws, before, during and after treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">HER2 BATs is the name for the T-cell immunotherapy you will receive. </li> <li class="seamTextUnorderedListItem">BATs is short for bi-specific antibody armed T-cells. </li> <li class="seamTextUnorderedListItem">Although trastuzumab (Herceptin®) is used to make the BATs, women do not need to have HER2+ breast cancer to take part in the study.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03661424' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/impatient-science/understanding-immunology' target='_blank'>Dr. Susan Love Foundation: Cancer Immunology</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tandfonline.com/doi/full/10.1080/2162402X.2018.1500672' target='_blank'>OncoImmunology Journal: BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases</a> </li></ul>
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