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(Last updated: July 03, 2020)

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1

NEAREST SITE: 2561 miles
Memorial Sloan Kettering Bergen (Consent and Follow-Up)
Montvale,NJ

VISITS: At least 2 visits over 3-6 weeks; may include hospital stay

PHASE: I-II

NCT ID: NCT02414269

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Has Spread to the Pleura

A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin Scientific Title

Purpose
To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the pleura.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: CAR T-Cells only</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells) <i class="seamTextEmphasis">followed 3-6 weeks later by:</i></li> <li class="seamTextUnorderedListItem">Acetaminophen and diphenhydramine, by mouth or by IV </li> <li class="seamTextUnorderedListItem">iCasp9M28z CAR T-cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: CAR T-Cells with chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells) <i class="seamTextEmphasis">followed 3-6 weeks later by:</i></li> <li class="seamTextUnorderedListItem">Acetaminophen and diphenhydramine, by mouth or by IV</li> <li class="seamTextUnorderedListItem">iCasp9M28z CAR T-cells, by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay may be required.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell therapy is a personalized immunotherapy made from your own white blood cells. </li> <li class="seamTextUnorderedListItem">The blood cells are removed from you, and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The pleura is the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. </li> <li class="seamTextUnorderedListItem">This CAR T-cell therapy is designed to target proteins found on cancer cells in the pleura.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy is given along with acetaminophen and diphenhydramine. These drugs are used to prevent infusion-related reactions.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02414269' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr. Susan Love Research Foundation: Chimeric Antigen Receptor T-Cell (CAR-T) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744527/' target='_blank'>Pubmed: Mesothelin-Targeted CARs: Driving T cells to Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/publications/targeted-therapy-news/2018/august-2018/early-signs-of-efficacy-seen-with-mesothelin-car-tcell-therapy' target='_blank'>Targeted Oncology: Early Signs of Efficacy Seen With Mesothelin CAR T-Cell Therapy</a> </li></ul>
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