Abstract

Core C is responsible for the production of clinical grade anfi-CD45 BCS antibody and anti CD20 1F5 antibody and their derivatization with DOTA and conjugation to streptavidin. These reagents will be produced, purified and vialed in the Biologies Production Facility of the Fred Hutchinson Cancer Research Center. In addition. Core C will be responsible for cGMP-compliant vialing of DOTA-biotin supplied in bulk form from a contract manufacturer (Macrocyclics, Inc.) Materials will be produced under current good manufactured practice (cGMP) conditions and Drug Master Files (DMFs) have been filed with the Food and Drug Administration (FDA).

Public Health Relevance

Through the refined development of clinical grade anti-CD45 BCS antibody and anti-CD20 1F5 antibody with streptavidin and DOTA, in our dedicated clinical manufacturing facility, the treatment of leukemia and lymphoma may become more successful and less invasive.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA044991-25
Application #
8546164
Study Section
Special Emphasis Panel (ZCA1-RPRB-J)
Project Start
Project End
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
25
Fiscal Year
2013
Total Cost
$251,610
Indirect Cost
$117,323

  Institution

Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109

  Publications

Green, Damian J; O'Steen, Shyril; Lin, Yukang et al. (2018) CD38-bispecific antibody pretargeted radioimmunotherapy for multiple myeloma and other B-cell malignancies. Blood 131:611-620
Budde, Lihua E; Wu, David; Martin, Daniel B et al. (2018) Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial. Br J Haematol 183:601-607
Greenbaum, Adam M; Green, Damian J; Holmberg, Leona A et al. (2018) Bendamustine, etoposide, and dexamethasone to mobilize peripheral blood hematopoietic stem cells for autologous transplantation in non-Hodgkin lymphoma. Blood Res 53:223-226
Green, Damian J; Press, Oliver W (2017) Whither Radioimmunotherapy: To Be or Not To Be? Cancer Res 77:2191-2196
O'Steen, Shyril; Green, Damian J; Gopal, Ajay K et al. (2017) Venetoclax Synergizes with Radiotherapy for Treatment of B-cell Lymphomas. Cancer Res 77:3885-3893
Cowan, Andrew J; Stevenson, Phillip A; Gooley, Ted A et al. (2017) Results of a phase I-II study of fenretinide and rituximab for patients with indolent B-cell lymphoma and mantle cell lymphoma. Br J Haematol 176:583-590
Shadman, Mazyar; Gopal, Ajay K; Kammerer, Britt et al. (2016) Radioimmunotherapy consolidation using 131I-tositumomab for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma in first remission. Leuk Lymphoma 57:572-6
Rufener, Gregory A; Press, Oliver W; Olsen, Philip et al. (2016) Preserved Activity of CD20-Specific Chimeric Antigen Receptor-Expressing T Cells in the Presence of Rituximab. Cancer Immunol Res 4:509-19
Graf, Solomon A; Gopal, Ajay K (2016) Idelalisib for the treatment of non-Hodgkin lymphoma. Expert Opin Pharmacother 17:265-74
Chen, Robert; Gopal, Ajay K; Smith, Scott E et al. (2016) Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood 128:1562-6

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