Monday, June 30, 2025 6/30/2025

Randomized trial of viral specific T-cell infusion to prevent viral infection after hematopoietic stem cell transplant.

Award Number: U01AI157620
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Randomized trial of viral specific T-cell infusion to prevent viral infection after hematopoietic stem cell transplant. - ABSTRACT Hematopoietic stem cell transplantation (HSCT) is a highly effective treatment, but serious virus infections occur in 82% of children undergoing HSCT at our institution and others. Current anti- viral drugs have inadequate response rates, prolong hospitalizations, and are frequently associated with organ toxicity. An alternative cellular therapy approach uses engineered viral specific T-lymphocytes (VSTs) manufactured from blood donated by a patient’s stem cell donor. VST therapy is highly effective when cells are infused in response to viremia, with response rates of over 80%. We seek to make a critical advance in this technology by testing whether scheduled administration of bone marrow donor derived VSTs 21 days after HSCT will be safe and at least as effective as our current pre-emptive treatment approach of only administering VSTs once viral reactivation or infection has occurred. We propose two specific aims. Specific Aim 1: Randomized comparison of donor-derived scheduled vs treatment VSTs in HSCT recipients to prevent viral infections. Hypothesis: Recipients of scheduled VSTs given 21 days after stem cell infusion will have a significantly lower frequency of viremia and invasive viral infections 100 days after HSCT than patients randomized to treatment use of VST’s. Specific Aim 2: Identify product characteristics that predict response to therapy and compare responses in those with and without exposure to viral ligand. Hypothesis: Specific product characteristics can be established that will identify VST products likely to be clinically effective, and VSTs will persist in scheduled VST recipients without stimulation from viral ligand. Aim 2a: We will study the T cell response to adenovirus, EBV, CMV or BK virus, and product persistence by ELISpot testing, TCR clonogram and VST persistence using TCR sequencing to define more and less effective VST products, and to determine if VSTs expand and persist if they are infused on a schedule into a person with no active viral replication to provide ligand. Aim 2b: We will systematically assess HLA restriction of presentation of viral antigens, using peptide mapping and single antigen cell lines (SALs). These data are vital for future “third party” use of VSTs in persons without donor derived product. This clinical trial may change the paradigm of treatment for viral infections if we are able to show that prophylactic VST infusion prevents infections.


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 = $533,505 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	5	4/21/2025	NON-COMPETING CONTINUATION	$533,505
														Subtotal = $533,505

Issue Date FY: 2024 ( Subtotal = $753,425 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	001	4	6/10/2024	NON-COMPETING CONTINUATION	$0
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	4	4/11/2024	NON-COMPETING CONTINUATION	$753,425
														Subtotal = $753,425

Issue Date FY: 2023 ( Subtotal = $753,425 )
2023	2023	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	001	3	4/21/2023	NON-COMPETING CONTINUATION	$753,425
2023	2022	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	2	1/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $753,425

Issue Date FY: 2022 ( Subtotal = $753,425 )
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	2	5/2/2022	NON-COMPETING CONTINUATION	$753,425
														Subtotal = $753,425

Issue Date FY: 2021 ( Subtotal = $663,928 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Allergy and Infectious Diseases Research	000	1	6/23/2021	NEW	$663,928
														Subtotal = $663,928

Grand Total All Awards = $3,457,708

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Randomized trial of viral specific T-cell infusion to prevent viral infection after hematopoietic stem cell transplant.

Award Number: U01AI157620

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/01/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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