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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
4P30CA006973-53
Application #
9061619
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2016-05-01
Budget End
2017-04-30
Support Year
53
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
Johnson, Renee M; Fleming, Charles B; Cambron, Christopher et al. (2018) Race/Ethnicity Differences in Trends of Marijuana, Cigarette, and Alcohol Use Among 8th, 10th, and 12th Graders in Washington State, 2004-2016. Prev Sci :
Marrone, Kristen A; Zhou, Xian; Forde, Patrick M et al. (2018) A Randomized Phase II Study of Metformin plus Paclitaxel/Carboplatin/Bevacizumab in Patients with Chemotherapy-Naïve Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Oncologist 23:859-865
Bar-Shir, Amnon; Alon, Lina; Korrer, Michael J et al. (2018) Quantification and tracking of genetically engineered dendritic cells for studying immunotherapy. Magn Reson Med 79:1010-1019
Altekruse, Sean F; Shiels, Meredith S; Modur, Sharada P et al. (2018) Cancer burden attributable to cigarette smoking among HIV-infected people in North America. AIDS 32:513-521
Dean, Lorraine T; Nicholas, Lauren Hersch (2018) Using Credit Scores to Understand Predictors and Consequences of Disease. Am J Public Health 108:1503-1505
Litvak, Anya; Batukbhai, Bhavina; Russell, Stuart D et al. (2018) Racial disparities in the rate of cardiotoxicity of HER2-targeted therapies among women with early breast cancer. Cancer 124:1904-1911
Kandala, Sri Kamal; Liapi, Eleni; Whitcomb, Louis L et al. (2018) Temperature-controlled power modulation compensates for heterogeneous nanoparticle distributions: a computational optimization analysis for magnetic hyperthermia. Int J Hyperthermia :1-15
Teply, Benjamin A; Wang, Hao; Luber, Brandon et al. (2018) Bipolar androgen therapy in men with metastatic castration-resistant prostate cancer after progression on enzalutamide: an open-label, phase 2, multicohort study. Lancet Oncol 19:76-86
Anchoori, Ravi K; Jiang, Rosie; Peng, Shiwen et al. (2018) Covalent Rpn13-Binding Inhibitors for the Treatment of Ovarian Cancer. ACS Omega 3:11917-11929
Shanbhag, Satish; Ambinder, Richard F (2018) Hodgkin lymphoma: A review and update on recent progress. CA Cancer J Clin 68:116-132

Showing the most recent 10 out of 2393 publications