Wednesday, August 20, 2025 8/20/2025

Optimization of peripheral blood mononuclear cell (PBMC) processing for robust downstream functional immune cell analysis and correlation with therapeutic efficacy

Award Number: U01CA267985
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2022
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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Optimization of peripheral blood mononuclear cell (PBMC) processing for robust downstream functional immune cell analysis and correlation with therapeutic efficacy - There is an increasing dependence on sophisticated biomarker development to allow prediction of therapeutic response as well as detection of potential underlying drug targets for novel therapeutics. A frequent limitation for solid tumors is that standard tissue biopsies are not always feasible, safe or easily repeated during treatment. Optimal sample acquisition, processing, and final validation are critical for any biomarker, regardless of source. Moreover, with the advent of immunotherapy, repeated sampling has become even more critical to understand the tumor and systemic immune response to better predict response and prevent resistance. Accordingly, there is an urgent need to develop reliable and valid alternatives to tissue biopsies. Peripheral blood is easy and safe to obtain and is more readily obtainable before, during, and after treatment. Peripheral blood mononuclear cells (PBMCs) can be isolated from standard whole blood and subsequent isolation and analysis of protein, DNA and RNA has the potential to serve as a surrogate for tissue response to anti-cancer therapy. However, analysis of immune functions more reflective of the systemic and tumor immune response to immunotherapy, using PBMCs, requires unusually rigorous processing techniques. We have found, for example, that reproducible viability of fresh samples is important for functional responses including cellular cytotoxicity and chemotaxis. However, fresh processing with subsequent analysis often requires flexible staffing and constant instrumentation availability due the unpredictable timing of patient sample collection. Furthermore, requiring immediate analysis may preclude the benefits of batching samples. The central hypothesis of this proposal is that optimizing PBMC processing will allow for delayed and more comprehensive, reproducible functional analyses that reflect the patient immune and tumor status permitting clinical treatment decisions without the requirement of a tissue biopsy. The hypothesis will be tested by first determining the optimal collection, processing and storage conditions that maximize long-term viability and sustain intact downstream meaningful functional immune analyses even when performed in a delayed batch manner. Second, we will determine if the reproducible PBMC functional outcomes serve as a surrogates to tumor infiltrating immune cell function and therapeutic efficacy. This approach will allow the advancement of peripheral blood biospecimens to reflect underlying mechanisms of tumor behavior previously relegated to the invasive tissue biopsy. In addition, we will have established conditions for processing PBMCs that allow for reproducible collection of viable cells that maintain functional capacity upon storage, from which meaningful functional assays can be performed by different facilities. The fundamental knowledge obtained from this proposal will facilitate the development of suitable correlative PBMC analyses for future clinical trials allowing for an easily obtained patient specimen that can determine treatment and clinical responses in real time to immunotherapy and other anti-cancer therapy.


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 = $369,546 )
2025	2025	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	000	4	1/28/2025	NON-COMPETING CONTINUATION	$332,592
2025	2025	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	001	4	5/22/2025	NON-COMPETING CONTINUATION	$36,954
														Subtotal = $369,546

Issue Date FY: 2024 ( Subtotal = $364,542 )
2024	2024	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	003	3	8/23/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	002	3	4/17/2024	NON-COMPETING CONTINUATION	$19,186
2024	2024	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	001	3	3/5/2024	NON-COMPETING CONTINUATION	$345,356
2024	2023	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	000	2	1/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $364,542

Issue Date FY: 2023 ( Subtotal = $350,377 )
2023	2023	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	001	2	6/19/2023	NON-COMPETING CONTINUATION	$350,377
2023	2022	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	000	1	3/15/2023	NEW	$0
														Subtotal = $350,377

Issue Date FY: 2022 ( Subtotal = $353,556 )
2022	2022	UNIVERSITY OF CINCINNATI	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Cancer Treatment Research	000	1	2/8/2022	NEW	$353,556
														Subtotal = $353,556

Grand Total All Awards = $1,438,021

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Optimization of peripheral blood mononuclear cell (PBMC) processing for robust downstream functional immune cell analysis and correlation with therapeutic efficacy

Award Number: U01CA267985

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 02/15/2022

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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