The application of T cell-based immunotherapies to augment the anti-tumor and/or anti-viral immune responses following autologous or allogeneic blood or marrow transplantation (BMT) has dramatically increased over the past several years. The development and translation of these T cell-based immunotherapy products for clinical applications requires scientific and technical expertise, highly skilled manufacturing staff, and a facility that meets the regulatory requirements to perform the clinical manufacturing procedures. Therefore, the principle objective of the Cell Processing Core is to support the projects in this program project grant by providing the cell processing expertise and facilities for the manufacture of the T cell-based immunotherapy products that have been developed and validated by the scientific teams at The Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center Cell Therapy Laboratory (JHM-SKCCC-CTL) and Children National Health System?s Cell Enhancement and Technologies for Immunotherapy Cell Therapy Laboratory (CNHS-CETI-CTL). Both facilities operate under current Good Manufacturing Tissue/Manufacturing Practices (cGTP/cGMP) conditions, appropriate for the manufacture of clinical products administered to patients. Specifically, JHM-SKCCC-CTL will manufacture activated marrow infiltrating lymphocytes (aMILs) T cell therapy products for Project 2; the CNHS- CETI-CLT program will manufacture two separate T cell therapy products, 1) T cells targeting tumor-associated antigens (TAA-T), and 2) T cells targeting HIV (HXTC) antigens, for Project 3. Both cell processing teams and facilities have extensive and complementary expertise to successfully meet the T cell therapy product needs proposed in these program projects.
Cell Processing Core Project Narrative The Cell Processing Core supports this program project grant by manufacturing the T cell immunotherapy products proposed for patients enrolled in clinical trials for Projects 2 and 3. The Cell Processing Core will work in concert with Core A as well as the leaders from Project 2 and Project 3 to manufacture the products and assist with translating basic science to the clinic when necessary.
