Seminal gene-modified tumor cell-based clinical trials were initiated and have continued for nearly fifteen years at Johns Hopkins University (JHU). The Cell Processing and Gene Therapy Core (CPGT) was established in 2000 to manufacture clinical grade biotherapeutic material for Phase l/ll clinical gene therapy trials at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins. Oversight and resource utilization of the CPGT occurs under the direction of a dedicated Committee. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of four manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC);all labs operate under shared management and oversight. This Core has been utilized by 17 faculty members who represent eleven Programs within the SKCCC. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials. The mission of the Core is to: 1) produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations, 2) manufacture novel biological oncolytic agents and clinical grade biotherapeutic reagents that require cGMP, as mandated by the FDA, 3) serve as a regulatory resource to the JHUSOM in the preparation of cell and gene-therapy based INDs, and 4) provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC Cores and laboratories. To date the CPGT Core has manufactured 32 different types of products including master cell banks, working cell banks, and clinical lots. This Core has been responsible for 14 SKCCC principal investigator sponsored Phase l/ll INDs supporting 24 clinical protocols with over 466 patients treated. This Core continues to facilitate clinical development of novel cancer therapies. Lay: The goal of the CPGT is to produce clinical grade biologic therapies for testing in early phase clinical trials that meet the regulatory conditions set forth by the United States FDA. These therapies are developed by SKCCC investigators and include vaccines, antibodies, peptides, and cancer targeting bacterial agents.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Johns Hopkins University
United States
Zip Code
Zeidner, Joshua F; Zahurak, Marianna; Rosner, Gary L et al. (2015) The evolution of treatment strategies for patients with chronic myeloid leukemia relapsing after allogeneic bone marrow transplant: can tyrosine kinase inhibitors replace donor lymphocyte infusions? Leuk Lymphoma 56:128-34
Penet, Marie-France; Shah, Tariq; Bharti, Santosh et al. (2015) Metabolic imaging of pancreatic ductal adenocarcinoma detects altered choline metabolism. Clin Cancer Res 21:386-95
Sharabi, Andrew B; Nirschl, Christopher J; Kochel, Christina M et al. (2015) Stereotactic Radiation Therapy Augments Antigen-Specific PD-1-Mediated Antitumor Immune Responses via Cross-Presentation of Tumor Antigen. Cancer Immunol Res 3:345-55
Peltonen, Karita; Colis, Laureen; Liu, Hester et al. (2014) A targeting modality for destruction of RNA polymerase I that possesses anticancer activity. Cancer Cell 25:77-90
DeZern, Amy E; Guinan, Eva C (2014) Aplastic anemia in adolescents and young adults. Acta Haematol 132:331-9
Paller, Channing J; Wissing, Michel D; Mendonca, Janet et al. (2014) Combining the pan-aurora kinase inhibitor AMG 900 with histone deacetylase inhibitors enhances antitumor activity in prostate cancer. Cancer Med 3:1322-35
Maldonado, Leonel; Teague, Jessica E; Morrow, Matthew P et al. (2014) Intramuscular therapeutic vaccination targeting HPV16 induces T cell responses that localize in mucosal lesions. Sci Transl Med 6:221ra13
Schweizer, Michael T; Antonarakis, Emmanuel S (2014) Chemotherapy and its evolving role in the management of advanced prostate cancer. Asian J Androl 16:334-40
Huang, Peng; Ou, Ai-hua; Piantadosi, Steven et al. (2014) Formulating appropriate statistical hypotheses for treatment comparison in clinical trial design and analysis. Contemp Clin Trials 39:294-302
Bhatnagar, Akrita; Wang, Yuchuan; Mease, Ronnie C et al. (2014) AEG-1 promoter-mediated imaging of prostate cancer. Cancer Res 74:5772-81

Showing the most recent 10 out of 357 publications