Phase I Study of Adoptive T-Cell Therapy With HER-2/Neu (HER-2)-Specific Memory CD8+ T Lymphocytes Obtained Following In Vivo Priming With a Peptide Vaccine in Patients With Advanced Stage HER-2-Positive Breast Cancer
I. To evaluate the feasibility of expanding HER-2-specific effector T cells (TE) ex vivo
from CD62L+ TCM and CD62L- TEM from patients immunized with a HER-2 peptide vaccine.
II. To evaluate the safety of infusing autologous ex vivo expanded HER-2-specific T cells
into patients with advanced HER-2+ breast cancer.
I. To evaluate the persistence, function, and phenotype of adoptively transferred
HER-2-specific TE cells derived from TCM or TEM precursors.
II. To investigate the potential anti-tumor effects of therapy with ex vivo expanded
HER-2-specific T cells in patients with advanced HER-2+ breast cancer.
OUTLINE : This is a dose-escalation study of ex vivo-expanded HER2-specific T cells.
VACCINE THERAPY: Patients receive HER2 peptide vaccine intradermally once weekly for 3
CHEMOTHERAPY: Patients receive cyclophosphamide IV on day -1.
IMMUNOTHERAPY: Patients receive ex vivo-expanded HER2 specific T-cell IV over 30 minutes on
days 1, 10, and 20.
After completion of study treatment, patients are followed up on days 28, 35, 49, 63 and
then monthly thereafter for 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ability to expand HER-2-specific T cells ex vivo from memory T cell subsets which are derived from patients with advanced HER-2 expressing cancer
Ability to expand HER-2-specific T cells ex vivo from memory T cell subsets which are derived from patients with advanced HER-2 expressing cancer will be defined as feasible if the minimum target expansion of HER-2-specific T cells is achieved in ≥2/3 expansions in ≥7/10 subjects.
After leukapheresis (2 weeks after 3rd vaccination) and prior to chemotherapy
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|