All four of the projects in this SPORE include clinical trials using cellular immunotherapy. These require a GMP manufacturing facility for the preparation of clinical grade vectors-and cellular therapy products. The GMP Facilities at the Center for Cell and Gene Therapy have been in operation for more than 13 years, recently relocating to one of the largest and most modern academic facilities of its type. The Cell Processing Facility (CPF) has considerable experience in the preparation of a wide variety of cellular products, including all that would be prepared for the SPORE projects. The CPF has been designated one of five National Somatic Cell Therapy Processing Facilities by the NHLBI under its Production Assistance for Cell Therapy Contract Program. The Vector Production Facility, which would also be a part of the Core, has produced more than 50 clinical grade adeno and retroviral vectors for local, national and international clinical studies and was a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing master and working cell banks. The final components of this Core are the Quality Control Laboratory, which performs in-house testing of cellular products and vectors, and is responsible for environmental monitoring of the GMP areas, and the Quality Assurance Group that ensures compliance with GMP and provides independent overview of all aspects of product manufacturing, testing, release and distribution. The GMP staff also have extensive regulatory experience that will facilitate the translation of laboratory studies into clinical trials.

Public Health Relevance

The Cell Processing and Vector Production Core manufactures cells and vectors that are given to patients on clinical trials in a safe manner with appropriate quality control. It is an essential component of the SPORE since it provides services that are vital to the implementation of the clinical studies.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Specialized Center (P50)
Project #
Application #
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Baylor College of Medicine
United States
Zip Code
Iwahori, Kota; Kakarla, Sunitha; Velasquez, Mireya P et al. (2015) Engager T cells: a new class of antigen-specific T cells that redirect bystander T cells. Mol Ther 23:171-8
Ngo, Minhtran Charlotte; Ando, Jun; Leen, Ann M et al. (2014) Complementation of antigen-presenting cells to generate T lymphocytes with broad target specificity. J Immunother 37:193-203
Ok, Chi Young; Li, Ling; Xu-Monette, Zijun Y et al. (2014) Prevalence and clinical implications of epstein-barr virus infection in de novo diffuse large B-cell lymphoma in Western countries. Clin Cancer Res 20:2338-49
Bollard, Catherine M; Gottschalk, Stephen; Torrano, Vicky et al. (2014) Sustained complete responses in patients with lymphoma receiving autologous cytotoxic T lymphocytes targeting Epstein-Barr virus latent membrane proteins. J Clin Oncol 32:798-808
Rouce, Rayne H; Louis, Chrystal U; Heslop, Helen E (2014) Epstein-Barr virus lymphoproliferative disease after hematopoietic stem cell transplant. Curr Opin Hematol 21:476-81
Leen, Ann M; Heslop, Helen E; Brenner, Malcolm K (2014) Antiviral T-cell therapy. Immunol Rev 258:12-29
Xu, Xin; Hegazy, Wael A H; Guo, Linjie et al. (2014) Effective cancer vaccine platform based on attenuated salmonella and a type III secretion system. Cancer Res 74:6260-70
Zhou, Xiaoou; Di Stasi, Antonio; Tey, Siok-Keen et al. (2014) Long-term outcome after haploidentical stem cell transplant and infusion of T cells expressing the inducible caspase 9 safety transgene. Blood 123:3895-905
Papadopoulou, Anastasia; Krance, Robert A; Allen, Carl E et al. (2014) Systemic inflammatory response syndrome after administration of unmodified T lymphocytes. Mol Ther 22:1134-8
Anurathapan, Usanarat; Leen, Ann M; Brenner, Malcolm K et al. (2014) Engineered T cells for cancer treatment. Cytotherapy 16:713-33

Showing the most recent 10 out of 121 publications