Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells
Although the etiology of CTCL is not completely understood, immunologic factors appear to
play an important role.
Dendritic Cell (DC)-tumor cell vaccines have several features that suggest applications for
the immunotherapy of human tumors. Importantly, DC-tumor cell immunization has the
potential to simultaneously stimulate CD4+ and CD8+ T cell-mediated immunity against
multiple tumor antigens.
The vaccine will be prepared from the subject's own blood, obtained during leukapheresis.
From leukapheresed blood, monocyte-derived DCs and malignant lymphocytes will be isolated.
The DCs will then be loaded with lymphocyte-derived tumor antigens. Formulations and
release criteria must be met before vaccine can be administered.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
Larisa J. Geskin, M.D.
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Medical Center, Department of Dermatology||Pittsburgh, Pennsylvania 15213|