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(Last updated: October 21, 2020)

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1

NEAREST SITE: 441 miles
UCSD Moores Cancer Center
San Diego,CA

VISITS: Weekly visits for 3 weeks

PHASE: I

NCT ID: NCT03841110

FT500 Alone or With Immunotherapy for Advanced HER2-positive Breast Cancer

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of giving FT500 alone or with immunotherapy.
Who is this for?
People with HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. Your cancer must have progressed after being treated with nivolumab (Opdivo®), pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®).    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500, by IV, weekly, for 3 weeks</li> <li class="seamTextUnorderedListItem">Cyclophosphamide and Fludarabine</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500, by IV, weekly for 3 weeks</li> <li class="seamTextUnorderedListItem">Combined with an Immune Checkpoint Inhibitor: Nivolumab (Opdivo®), Pembrolizumab (Keytruda®) or Atezolizumab (Tecentriq®) </li> <li class="seamTextUnorderedListItem">Cyclophosphamide and Fludarabine</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500 is a natural killer (NK) cell immunotherapy. </li> <li class="seamTextUnorderedListItem">NK cells are specialized immune cells that can fight cancer cells. </li> <li class="seamTextUnorderedListItem">Cyclophosphamide and fludarabine are chemotherapy drugs used to deplete lymph cells.</li> <li class="seamTextUnorderedListItem">Opdivo, Tecentriq and Keytruda are each a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. They are approved to treat certain other types of cancers, but their use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03841110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.ucsd.edu/news/releases/Pages/2019-04-01-UC-San-Diego-Health-Treats-Cancer-Patient-with-Stem-Cell-Derived-Natural-Killer-Cells.aspx' target='_blank'>UCSD Health: UC San Diego Health Treats 1st Cancer Patient with Stem-Cell Derived Natural Killer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.the-scientist.com/news-opinion/clinical-trial-underway-for-a-natural-killer-cell-therapy-65845' target='_blank'>The Scientist: Clinical Trial Underway for a Natural Killer Cell Therapy</a> </li></ul>
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