Spots Global Cancer Trial Database for Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
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Trial Identification
Brief Title: Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Official Title: Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
Study ID: NCT05378464
Conditions
Study Description
Brief Summary: The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Detailed Description: Patients with HER2-positive (HER2+) metastatic breast cancer will be treated with 6 weekly injections of dendritic cell (DC1) vaccines in combination with trastuzumab and pepinemab. Investigators hypothesize these therapies will elicit CD4+ HER2 specific T cell responses. HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide. Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moffitt Cancer Center, Tampa, Florida, United States
Contact Details
Name: Heather Han, MD
Affiliation: Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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