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BMT Core - Stanford University

Award Number: UG1HL069291
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2001
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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BMT Core - Stanford University - This is a renewal application to RFA-HL-24-010 to propose that the Division of Blood and Marrow Transplantation and Cellular Therapy (BMT-CT) at Stanford University continue as a Core Clinical Center for the BMT Clinical Trials Network (BMT CTN). Stanford’s Program will perform ~700 adult transplants/cellular therapies in 2023 including autologous and allogeneic transplants using cells from matched and mismatched related and unrelated donors, cord blood units, ex vivo manipulated cell products and genetically modified cells, as well as novel chimeric antigen receptor T cell products. Stanford’s BMT-CT Program participates in basic and clinical research as a single institution, and within regional, national and international consortia. The Division is supported by a NIH Program Project Grant with over 32 years of funding of basic scientific research and clinical translational trials that advance the field. The Program is strengthened by highly experienced biostatics and data management groups, and a cGMP-compliant, FACT and CLIA certified Cellular Therapy Facility for routine cell processing and the development of investigational cellular therapies. The Program is a high accrual BMT CTN center and has enrolled 579 patients to 25 CTN studies. In the past granting period, Stanford investigators served in leadership roles of both committees and clinical trial protocols. Additionally, Stanford faculty participated on several protocol development committees and on other steering committees and task forces. Stanford will continue to leverage the capabilities of its Program to support the research goals of the CTN. It is our collective mission to advance the field of BMT-CT for patients with rare and difficult to treat blood diseases through high quality multi-center clinical trials. The goal of the proposed protocol in the current application is to determine whether a novel strategy can prevent and reduce the risk of developing graft-versus-host disease (GVHD) in patients lacking HLA matched donors, and thereby improve upon traditional allogeneic BMT. We propose a phase 1/2 clinical trial to evaluate the safety and efficacy of Orca-T, an engineered donor graft in which a highly purified Treg product is administered the same day as hematopoietic stem and progenitor cells followed 2 days later by conventional CD3+ T cells. The target population is patients with ALL, MDS, or AML receiving myeloablative conditioning followed by HCT using HLA mismatched unrelated donors (MMURDs). This investigator-initiated study builds upon our prior preclinical and clinical work with the Orca-T graft engineering platform in the HLA matched donor setting. The primary outcome of the Phase 2 portion is efficacy, as defined by GVHD-relapse-free survival (GRFS) at one year following HCT. Based on aggregated data, we hypothesize that the Orca-T allograft in combination with dual-agent GVHD prophylaxis (tacrolimus plus ruxolitinib) will synergistically and significantly reduce rates of GVHD in adults undergoing myeloablative allogeneic HCT with MMURDs. The Stanford BMT-CT program is committed to continued participation in BMT CTN trials, contributing concepts for consideration by the Network, and participating in Network committees and citizenship activities.


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 = $231,600 )
2026	2026	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	26	7/22/2026	NON-COMPETING CONTINUATION	$231,600
														Subtotal = $231,600

Issue Date FY: 2025 ( Subtotal = $231,600 )
2025	2025	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	001	25	8/19/2025	NON-COMPETING CONTINUATION	$231,600
2025	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	23	4/2/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $231,600

Issue Date FY: 2024 ( Subtotal = $231,600 )
2024	2024	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	24	8/9/2024	COMPETING CONTINUATION	$231,600
														Subtotal = $231,600

Issue Date FY: 2023 ( Subtotal = $136,601 )
2023	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	001	23	6/29/2023	NON-COMPETING CONTINUATION	$136,601
2023	2022	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	22	1/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $136,601

Issue Date FY: 2022 ( Subtotal = $140,080 )
2022	2022	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	22	7/1/2022	NON-COMPETING CONTINUATION	$140,080
														Subtotal = $140,080

Issue Date FY: 2021 ( Subtotal = $143,454 )
2021	2021	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	21	7/29/2021	NON-COMPETING CONTINUATION	$143,454
														Subtotal = $143,454

Issue Date FY: 2020 ( Subtotal = $146,732 )
2020	2020	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	20	6/9/2020	NON-COMPETING CONTINUATION	$146,732
														Subtotal = $146,732

Issue Date FY: 2019 ( Subtotal = $149,913 )
2019	2019	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 SERRA MALL	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	19	7/5/2019	NON-COMPETING CONTINUATION	$149,913
														Subtotal = $149,913

Issue Date FY: 2018 ( Subtotal = $172,951 )
2018	2018	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 SERRA MALL	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	18	6/13/2018	NON-COMPETING CONTINUATION	$145,353
2018	2017	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 SERRA MALL	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	001	17	9/18/2018	COMPETING CONTINUATION	$27,598
														Subtotal = $172,951

Issue Date FY: 2017 ( Subtotal = $141,316 )
2017	2017	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 SERRA MALL	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	000	17	7/27/2017	COMPETING CONTINUATION	$141,316
2017	2017	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 SERRA MALL	STANFORD	CA	94305	SANTA CLARA	USA	Blood Diseases and Resources Research	001	17	8/22/2017	COMPETING CONTINUATION	$0
														Subtotal = $141,316

Grand Total All Awards = $1,725,847

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BMT Core - Stanford University

Award Number: UG1HL069291

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2001

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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