Abstract

? CORE C Core C is responsible for the production of clinical grade anti-human CD45 BC8 antibody (Project 1) and anti- canine CD45 (CA12.10C12) for pre-clinical use (Projects 2 and 3). Each antibody will be conjugated with a reagent (B10-NCS) for radiolabeling with astatine-211. All antibodies and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility of the Fred Hutchinson Cancer Research Center. Pre-clinical and clinical radiolabeling reactions will be conducted in appropriate radiochemistry laboratories at the University of Washington. Clinical grade BC8-B10 will be produced under current good manufacturing practice (cGMP) conditions and a Drug Master File will be developed and submitted to the Food and Drug Administration. In addition, Core C will be responsible for the establishment of an IND to support conduct of Phase I human clinical trials.

Public Health Relevance

? CORE C The anti-CD45 antibodies produced in our dedicated clinical manufacturing facilities will be critical for use in key clinical and pre-clinical radioimmunotherapy studies, which will ultimately lead to development of minimally toxic hematopoietic cell transplant regimens for the treatment of patients with nonmalignant hematologic diseases.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Program Projects (P01)
Project #
5P01HL122173-04
Application #
9486985
Study Section
Heart, Lung, and Blood Initial Review Group (HLBP)
Program Officer
El Kassar, Nahed
Project Start
Project End
Budget Start
2018-06-01
Budget End
2019-05-31
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost

  Institution

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

  Publications

Li, Yawen; Hamlin, Donald K; Chyan, Ming-Kuan et al. (2018) cGMP production of astatine-211-labeled anti-CD45 antibodies for use in allogeneic hematopoietic cell transplantation for treatment of advanced hematopoietic malignancies. PLoS One 13:e0205135
Georges, George E; Doney, Kris; Storb, Rainer (2018) Severe aplastic anemia: allogeneic bone marrow transplantation as first-line treatment. Blood Adv 2:2020-2028
Adair, Jennifer E; Chandrasekaran, Devikha; Sghia-Hughes, Gabriella et al. (2018) Novel lineage depletion preserves autologous blood stem cells for gene therapy of Fanconi anemia complementation group A. Haematologica 103:1806-1814
Thakar, M S; Bonfim, C; Walters, M C et al. (2017) Dose-adapted post-transplant cyclophosphamide for HLA-haploidentical transplantation in Fanconi anemia. Bone Marrow Transplant 52:570-573
Hill, Joshua A; Mayer, Bryan T; Xie, Hu et al. (2017) The cumulative burden of double-stranded DNA virus detection after allogeneic HCT is associated with increased mortality. Blood 129:2316-2325
Burroughs, Lauri M; Shimamura, Akiko; Talano, Julie-An et al. (2017) Allogeneic Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for Treatment of Marrow Failure Disorders. Biol Blood Marrow Transplant 23:1669-1677
McDonald, George B; Tabellini, Laura; Storer, Barry E et al. (2017) Predictive Value of Clinical Findings and Plasma Biomarkers after Fourteen Days of Prednisone Treatment for Acute Graft-versus-host Disease. Biol Blood Marrow Transplant 23:1257-1263
Hill, Joshua A; Magaret, Amalia S; Hall-Sedlak, Ruth et al. (2017) Outcomes of hematopoietic cell transplantation using donors or recipients with inherited chromosomally integrated HHV-6. Blood 130:1062-1069
Shadman, Mazyar; Hingorani, Sangeeta; Lanum, Scott A et al. (2017) Allogeneic hematopoietic cell transplant for patients with end stage renal disease requiring dialysis - a single institution experience. Leuk Lymphoma 58:740-742
Aki, S Z; Inamoto, Y; Carpenter, P A et al. (2016) Confounding factors affecting the National Institutes of Health (NIH) chronic Graft-Versus-Host Disease Organ-Specific Score and global severity. Bone Marrow Transplant 51:1350-1353

Showing the most recent 10 out of 21 publications