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Therapeutic implication of CD38 in CLL

Award Number: R01CA233790
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/04/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Therapeutic implication of CD38 in CLL - Project Summary The objective of this proposal is to decipher the mechanisms involved in CD38 signaling in patients with chronic lymphocytic leukemia (CLL, a B-cell cancer); how its increased expression drives an aggressive clinical course and whether its targeted therapeutic disruption can be beneficial for patients. CD38 is expressed on all hematopoietic tissues and functions as both an ecto-enzyme to regulate NAD metabolism and as a co-receptor to amplify signaling through the B-cell receptor (BCR) on B-cells and the T-cell receptor (TCR) on T-cells. Increased CD38 expression on CLL cells is associated with an unfavorable disease course in patients; resulting in shorter overall survival and time to treatment. While the role of CD38 as a negative prognostic marker in CLL has been established for over 2 decades, the therapeutic benefit to be derived by patients from its targeted inhibition, has, till date remained an open-ended subject. Much of this uncertainty has been due to lack of high-affinity, clinical-grade agents that can bind and inhibit CD38; thus, resulting in our inability to study the effects of CD38 disruption on CLL biology. Indeed, with the availability of Daratumumab, (Dara, anti-CD38 mAb, FDA-approved in multiple myeloma), as well as several other anti-CD38 mAbs and small molecule inhibitors in development, this issue will for the first time be appropriately addressed; by our group. Our preliminary data strongly indicates that targeting CD38 has a direct lethal effect on CLL cells, reduces the population of tumor-supportive T-regulatory cells (Tregs) and increases the quantity and functional capacity of tumor-specific CD8+ T-cells. These are novel observations and will be examined through the following aims where we will: 1. Determine the molecular processes of how CD38 activity in CLL cells promotes disease progression. 2. Elucidate the role of CD38 in the suppression of anti-tumor T-cell responses in vitro and in vivo. 3. Evaluate effects of Dara-based therapy in CLL patients on a phase II clinical trial. While the first two aims are highly mechanistic in nature, results from their completion will guide studies in Aim 3, where we will examine changes in CD38 enzymatic/receptorial activity and in the T-cell architecture in patients who are on Dara-based treatment (on an accompanying, but separately funded phase II study). Thus, our long-term goals are to understand the fundamentals of CD38 biology in the tumor cells themselves and in neighboring cells within the tumor microenvironment. Mechanistic insight into the processes engaged upon CD38 inhibition will propel more effective development of anti-CD38 treatments and no doubt lead to a paradigm shift- elevating CD38 from the category of a prognostic marker to a bonafide therapeutic target in CLL.


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: 2026 ( Subtotal = -$64,216 )
2026	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	5	1/14/2026	NON-COMPETING CONTINUATION	-$64,216
														Subtotal = -$64,216

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	5	8/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $565,086 )
2023	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	5	8/14/2023	NON-COMPETING CONTINUATION	$565,086
														Subtotal = $565,086

Issue Date FY: 2022 ( Subtotal = $598,011 )
2022	2022	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	4	8/11/2022	NON-COMPETING CONTINUATION	$598,011
														Subtotal = $598,011

Issue Date FY: 2021 ( Subtotal = $610,215 )
2021	2021	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	3	8/24/2021	NON-COMPETING CONTINUATION	$610,215
														Subtotal = $610,215

Issue Date FY: 2020 ( Subtotal = $610,215 )
2020	2020	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	2	8/4/2020	NON-COMPETING CONTINUATION	$610,215
														Subtotal = $610,215

Issue Date FY: 2019 ( Subtotal = $610,213 )
2019	2019	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Cancer Biology Research	000	1	9/4/2019	NEW	$610,213
														Subtotal = $610,213

Grand Total All Awards = $2,929,524

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Therapeutic implication of CD38 in CLL

Award Number: R01CA233790

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/04/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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