Tuesday, October 7, 2025 10/7/2025

Biomaterial Scaffolds for Ex Vivo and In Situ CAR-T Cell Production

Award Number: R37CA260223
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/02/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Biomaterial Scaffolds for Ex Vivo and In Situ CAR-T Cell Production - PROJECT SUMMARY Despite unprecedented clinical success of chimeric antigen receptor (CAR)-T cell therapy against tumors, widespread application is limited by lengthy and labor-intensive ex vivo manufacturing procedures that result in: (i) very high costs of therapy of up to half of a million dollars; (ii) delays of weeks or months to infuse CAR-T cells to patients with rapidly progressing disease; and (iii) heterogeneous composition and terminal differentiation of infused CAR-T cells as a result of ex vivo culture that limit CAR-T cell engraftment and persistence. Effort to overcome these limitations have focused on closed and automatic manufacturing devices to contain the labor needed to manufacture CAR-T cells ex vivo, and allogeneic off-the-shelf CAR-T cells have been proposed to overcome the need of CAR-T cell manufacturing for each single patient. Despite significant achievements in this space, reducing the time, costs and regulatory burden remains a deep unmet need in CAR-T cell therapy and significant reducing or eliminating ex vivo procedures remains a critical unmet need. In vivo generation of CAR-T cells would eliminate the need for ex vivo procedures, prevent the terminal differentiation of ex vivo expanded CAR-T cells and ensure the potency and longevity of autologous T cells as compared to allogeneic CAR-T cell products that are extensively manipulated to prevent rejection and graft- versus-host disease The research outlined in this proposal develops new biomaterials approaches to reduce the time and effort to produce CAR-T cells in vitro, to enhance CAR-T cell efficacy and persistence in vivo and, finally, to eliminate ex vivo manipulation entirely by generating CAR-T cells entirely within the patient. We propose that biomaterial scaffolds displaying anti-CD3/CD28 antibodies and releasing pro-proliferative interleukins will mediate simultaneous activation and viral transduction of T cells without centrifugation (spinoculation) or transduction agents (retronectin, polybrene) and will facilitate ex vivo genetic reprogramming of T cells by reducing the time and expense of activating naive T-cells and transducing them with viral vectors. We next propose that directly implanting scaffolds seeded with peripheral blood mononuclear cells and CAR- encoding viral vectors will promote release of CAR-T cells into circulation, eliminating ex vivo CAR-T isolation and proliferation protocols to promote a less differentiated cell phenotype associated with longer in vivo persistence. Finally, we propose that, through the inclusion of encapsulated T-cell attracting cytokines, implanted biomaterial scaffolds will generate CAR-T cells entirely in situ through recruitment of host T cells to the scaffold, in-scaffold reprogramming of recruited T cells with resident CAR-encoding viral vectors, and release of reprogrammed CAR-T cells. We expect that our results will provide a basis for a general cellular therapeutic strategy and promote widespread patient access. In addition to the obvious applications in blood cancers, this rational materials-based approach for cellular manufacturing will be adopted to program therapeutic lymphocytes in solid tumors and for other diseases.


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 = $386,587 )
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	005	6	4/2/2025	NON-COMPETING CONTINUATION	$289,942
2025	2025	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	003	4	3/5/2025	SUPPLEMENT FOR EXPANSION	$32,215
2025	2025	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	002	3	3/5/2025	SUPPLEMENT FOR EXPANSION	$32,215
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	006	6	5/28/2025	NON-COMPETING CONTINUATION	$32,215
2025	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	004	5	3/5/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$22,232
2025	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	000	5	12/4/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	003	4	3/5/2025	SUPPLEMENT FOR EXPANSION	-$5,781
2025	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	001	3	3/5/2025	NON-COMPETING CONTINUATION	$0
2025	2023	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	002	3	3/5/2025	SUPPLEMENT FOR EXPANSION	-$3,033
2025	2023	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	001	3	3/5/2025	NON-COMPETING CONTINUATION	-$13,418
														Subtotal = $386,587

Issue Date FY: 2024 ( Subtotal = $445,606 )
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	006	5	9/26/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	002	4	4/16/2024	NON-COMPETING CONTINUATION	$19,201
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	000	4	3/27/2024	NON-COMPETING CONTINUATION	$345,604
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Cancer Treatment Research	005	5	8/30/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$439,825
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	004	4	8/30/2024	SUPPLEMENT FOR EXPANSION	-$75,020
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	003	4	8/30/2024	NON-COMPETING CONTINUATION	-$364,805
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	001	4	4/3/2024	SUPPLEMENT FOR EXPANSION	$80,801
														Subtotal = $445,606

Issue Date FY: 2023 ( Subtotal = $461,377 )
2023	2023	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	000	3	3/21/2023	NON-COMPETING CONTINUATION	$376,324
2023	2023	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	001	3	4/5/2023	SUPPLEMENT FOR EXPANSION	$85,053
														Subtotal = $461,377

Issue Date FY: 2022 ( Subtotal = $384,005 )
2022	2022	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	000	2	3/14/2022	NON-COMPETING CONTINUATION	$345,601
2022	2022	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	001	2	5/3/2022	NON-COMPETING CONTINUATION	$38,404
														Subtotal = $384,005

Issue Date FY: 2021 ( Subtotal = $407,089 )
2021	2021	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	000	1	4/16/2021	NEW	$407,089
														Subtotal = $407,089

Grand Total All Awards = $2,084,664

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Biomaterial Scaffolds for Ex Vivo and In Situ CAR-T Cell Production

Award Number: R37CA260223

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/02/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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