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Mathematical Model-Guided Adoptive Immunotherapy in Bladder Cancer

Award Number: R01CA259387
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2021
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Mathematical Model-Guided Adoptive Immunotherapy in Bladder Cancer - Summary Bladder cancer is the fourth most common cancer in men and a leading cause of cancer mortality among men and women with the rates of bladder cancer incidents and bladder cancer-related deaths that have not decreased over the last 40 years. Therefore, novel more precise treatment strategies are desired. Bladder cancer has long been recognized as a malignancy that is responsive to immune-based therapy. One of the novel immunotherapy approaches utilizes the adoptive cell therapy (ACT), where autologous tumor-infiltrating T lymphocytes (TIL) are expanded and activated ex vivo and then reinfused into the cancer patient. However, typical systemic administration of ACT-TIL requires prior lymphodepletion and thus TIL are injected infrequently and in large numbers. Bladder is a specific organ which allows for intravesical delivery by direct administration of drugs and T cells through a catheter making it amenable to multiple and more frequent infusions of TIL and other therapeutics, potentially with smaller doses. This gives an unprecedented opportunity to use mathematical modeling integrated with pre-clinical mouse models to design, optimize and validate ACT-TIL combination therapies that will maximize tumor response and minimize toxicity. Our methods include microscopic- and macroscopic-level in silico models supported by in vitro, in vivo and ex vivo experimental data, defined T cells and a murine models of bladder cancer that mimic clinically-relevant procedures. In Aim 1, we will develop in silico models to enhance T cell infiltration into the bladder tumors. In Aim 2, we will optimize T cell properties ex vivo for the most effective T cell-cancer cell interactions. In Aim 3, we will apply our integrated methodology to design most effective combination therapy protocols to increase the effectiveness of reinfused TILs. The deliverables of this study will improve our understanding of how the bladder tumor microenvironment impacts T cell infiltration and T cell-tumor cell interactions and will lead to strategies that improve bladder cancer treatment by mathematically optimizing treatment schedules.


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 = $476,037 )
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	001	5	5/22/2025	NON-COMPETING CONTINUATION	$47,602
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	000	5	3/13/2025	NON-COMPETING CONTINUATION	$428,435
														Subtotal = $476,037

Issue Date FY: 2024 ( Subtotal = $452,237 )
2024	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	000	4	3/11/2024	NON-COMPETING CONTINUATION	$428,435
2024	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	001	4	4/18/2024	NON-COMPETING CONTINUATION	$23,802
														Subtotal = $452,237

Issue Date FY: 2023 ( Subtotal = $466,517 )
2023	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	000	3	2/24/2023	NON-COMPETING CONTINUATION	$466,517
														Subtotal = $466,517

Issue Date FY: 2022 ( Subtotal = $466,514 )
2022	2022	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	000	2	4/1/2022	NON-COMPETING CONTINUATION	$466,514
														Subtotal = $466,514

Issue Date FY: 2021 ( Subtotal = $470,293 )
2021	2021	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Treatment Research	000	1	3/4/2021	NEW	$470,293
														Subtotal = $470,293

Grand Total All Awards = $2,331,598

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Mathematical Model-Guided Adoptive Immunotherapy in Bladder Cancer

Award Number: R01CA259387

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2021

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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