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Preventing Relapse After Non-myeloablative Stem Cell Transplantation: The Final Challenge

Award Number: P01CA078902
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/12/1999
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Preventing Relapse After Non-myeloablative Stem Cell Transplantation: The Final Challenge - PROJECT SUMMARY / ABSTRACT - OVERALL The overall goal of this program project grant is to overcome disease relapse, which is the single-most important limitation of allogeneic hematopoietic cell transplant (HCT) in the treatment of older or medically infirm patients with myeloid malignancies and myeloma. Two principal approaches are proposed, understanding and enhancing graft-vs-tumor (GVT) effects after HCT and reducing the pre-HCT tumor burden by intensifying the conditioning regimen through innovative, first-in-human radioimmunotherapy (RIT) that has been entirely developed in our laboratories. Project 1 will lead to an understanding of how to enhance GVT effects using studies in a in vivo murine model and in a human in vitro model. Enhancing GVT effects will likely become an effective means of reducing the relapse problem. Projects 2 and 3 will employ novel first-in-human RIT technology using alpha- emitter astatine-211 (211At) conjugated to monoclonal antibodies that was first developed in murine and large animal models. This is now applied clinically in Phase I/II trials in patients with myeloid malignancies who have pre-HCT tumor including refractory disease and in patients with multiple myeloma. The principle addressed here is reducing the pre-transplant tumor burden, thereby shifting the balance in favor of the transplanted allogeneic donor lymphocytes. While RIT with an antibody to CD45, as proposed in Project 1, has been tolerated well in the ongoing dose-escalation trial, we expect that liver toxicity will be dose-limiting for myeloid malignancies. In order to get around that problem and to further minimize the toxicity profile of targeted RIT directed against CD45, Project 1 proposes to develop fully anti-human CD45 MAbs, with a series of MAb isotypes/variants, and then test the hypothesis that in vivo off-target toxicity of the RIT can be further minimized and 211At-anti-CD45 RIT be optimized by engineering of the MAb Fc portion to remove the potential to interact with Fc receptors, especially in the liver. Clinical trials in Project 3 will begin with a CD38 target for RIT and will next optimize the approach by switching to a B-cell maturation antigen (BCMA) target in order to achieve better efficacy of myeloma cell kill. In summary, work on the three projects will use a two-pronged approach at decreasing post-HCT relapse rates among patients with myeloid malignancies and multiple myeloma, reducing the pre-HCT tumor burden and enhancing post-HCT tumor kill through GVT effects. The outcomes of these studies have obvious bearings on allogeneic HCT in older patients with other hematologic malignancies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $2,074,913 )
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	27	6/6/2025	NON-COMPETING CONTINUATION	$207,492
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	27	4/25/2025	NON-COMPETING CONTINUATION	$1,867,421
														Subtotal = $2,074,913

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	26	9/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $2,074,913 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	26	9/21/2023	NON-COMPETING CONTINUATION	$41,498
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	26	9/14/2023	NON-COMPETING CONTINUATION	$2,033,415
														Subtotal = $2,074,913

Issue Date FY: 2022 ( Subtotal = $2,071,892 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	002	25	7/25/2022	NON-COMPETING CONTINUATION	$2,114,176
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	003	25	8/2/2022	NON-COMPETING CONTINUATION	-$42,284
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	23	6/8/2022	NON-COMPETING CONTINUATION	-$1,449,399
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	004	23	8/8/2022	NON-COMPETING CONTINUATION	-$29,919
2022	2021	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	24	6/8/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,449,399
2022	2021	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	005	24	8/8/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$29,919
														Subtotal = $2,071,892

Issue Date FY: 2021 ( Subtotal = $2,128,808 )
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	002	23	6/30/2021	NON-COMPETING CONTINUATION	$2,128,808
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	22	4/16/2021	COMPETING CONTINUATION	$0
2021	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	21	3/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,128,808

Issue Date FY: 2020 ( Subtotal = $1,846,796 )
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	22	9/18/2020	COMPETING CONTINUATION	$1,846,796
														Subtotal = $1,846,796

Issue Date FY: 2019 ( Subtotal = $984,084 )
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	21	8/14/2019	NON-COMPETING CONTINUATION	$984,084
														Subtotal = $984,084

Issue Date FY: 2018 ( Subtotal = $892,086 )
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	20	8/29/2018	NON-COMPETING CONTINUATION	$892,086
														Subtotal = $892,086

Issue Date FY: 2017 ( Subtotal = $2,023,730 )
2017	2017	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	19	8/14/2017	NON-COMPETING CONTINUATION	$2,023,730
														Subtotal = $2,023,730

Issue Date FY: 2016 ( Subtotal = $2,023,730 )
2016	2016	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	18	9/1/2016	NON-COMPETING CONTINUATION	$2,023,730
														Subtotal = $2,023,730

Issue Date FY: 2015 ( Subtotal = $2,019,079 )
2015	2015	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	17	9/2/2015	NON-COMPETING CONTINUATION	$2,019,079
														Subtotal = $2,019,079

Issue Date FY: 2014 ( Subtotal = $1,846,366 )
2014	2014	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	16	9/2/2014	COMPETING CONTINUATION	$1,846,366
2014	2013	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	15	8/26/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,846,366

Issue Date FY: 2013 ( Subtotal = $1,788,455 )
2013	2013	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	15	6/28/2013	NON-COMPETING CONTINUATION	$932,279
2013	2013	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	15	3/1/2013	NON-COMPETING CONTINUATION	$856,176
														Subtotal = $1,788,455

Issue Date FY: 2012 ( Subtotal = $1,909,574 )
2012	2012	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	14	4/12/2012	NON-COMPETING CONTINUATION	$1,909,574
														Subtotal = $1,909,574

Issue Date FY: 2011 ( Subtotal = $1,909,490 )
2011	2011	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	13	5/18/2011	NON-COMPETING CONTINUATION	$84,648
2011	2011	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	13	3/8/2011	NON-COMPETING CONTINUATION	$1,824,842
														Subtotal = $1,909,490

Issue Date FY: 2010 ( Subtotal = $1,955,836 )
2010	2010	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	12	4/27/2010	NON-COMPETING CONTINUATION	$1,955,836
														Subtotal = $1,955,836

Issue Date FY: 2009 ( Subtotal = $1,991,605 )
2009	2009	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	001	11	3/26/2009	COMPETING CONTINUATION	$1,991,605
2009	2008	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	10	3/23/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,991,605

Issue Date FY: 2008 ( Subtotal = $2,003,834 )
2008	2008	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Treatment Research	000	10	2/22/2008	NON-COMPETING CONTINUATION	$2,003,834
														Subtotal = $2,003,834

Issue Date FY: 2007 ( Subtotal = $1,985,492 ) (Continued on the next page)
Grand Total All Awards = $47,262,587

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Preventing Relapse After Non-myeloablative Stem Cell Transplantation: The Final Challenge

Award Number: P01CA078902

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/12/1999

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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