Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer

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.

Trial Details

NCT ID
NCT05378464
Phase
PHASE1
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Dendritic Cell (DC1) Vaccine
  • Trastuzumab
  • Pepinemab
  • T-Cell therapy
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Must have a histologically confirmed HER2 positive breast cancer and must be candidates for trastuzumab therapy as per current standard of care. No…
  • Patients will be eligible regardless of ER/PR status which will be determined per 2020 ASCO/CAP guideline and hormonal therapy will be allowed to c…
  • Must have evaluable disease, defined as at least one lesion that can be accurately measured ≥ 10 mm by standard imaging techniques that can be incl…
  • Must have had disease progression while on trastuzumab for the treatment of HER2+ MBC and received no more than 3 lines of cytotoxic chemotherapy i…

For full eligibility, visit ClinicalTrials.gov.

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