The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional) | RFA HL 24 010

Opportunity Information: Apply for RFA HL 24 010

The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional) funding opportunity (RFA-HL-24-010) is an NIH cooperative agreement designed to strengthen and operate a coordinated clinical trials network focused on improving hematopoietic cell transplantation (HCT) and related novel cell therapy (CT) strategies. The central aim is to move the field forward for all patients who may benefit from transplant or cellular therapies, with a clear emphasis on populations that are often hardest to study and treat, including people with rare, complex non-malignant blood disorders as well as patients with hematologic cancers. Rather than funding isolated single-site studies, the opportunity is structured to support an organized network capable of running multi-center trials, harmonizing procedures, and generating results that can change clinical practice.

A core feature of the program is the support for key network infrastructure. NIH intends to fund a Data Coordinating Center (DCC) along with multiple core clinical centers. The DCC typically provides the operational backbone for a network: coordinating protocol development and trial operations, managing data systems, ensuring data quality, supporting statistical design and analysis, and helping with regulatory and reporting requirements. The core clinical centers are the frontline sites where patients are enrolled and treated under study protocols, where transplant and cell therapy procedures are performed, and where outcomes are systematically collected over long follow-up periods. In addition to funding the network infrastructure, the initiative also supports a limited number of trials directly under this program, while anticipating that additional studies will be brought into the network through partnerships and co-funding arrangements.

The opportunity explicitly recognizes why transplant and cell therapy trials are unusually challenging to run within standard grant timeframes. Many target diseases are rare, which makes participant accrual slow and can require enrollment windows that extend as long as five years. There are also practical complexities related to cell collection, processing, manufacturing, and distribution, which can introduce delays and require stringent quality and coordination across sites. On top of that, many clinically meaningful endpoints in this space are long-term and sometimes composite measures, such as disease-free survival or chronic graft-versus-host disease (GVHD)-free survival, which may only be evaluable two or more years after transplant. Because of these realities, NIH indicates that a seven-year program period is needed to properly conduct and complete the types of trials this network is meant to support, rather than forcing studies to end before the most important outcomes can be measured.

This is a discretionary NIH funding opportunity using the cooperative agreement mechanism (UG1), which generally means the NIH will have substantial scientific and/or programmatic involvement in how the network operates compared with a traditional research project grant. The "clinical trial optional" label signals that applicants may propose activities that include clinical trials, but a clinical trial is not strictly required for every application; the emphasis is on building and maintaining the capacity to run and support these trials within the network structure.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding those that are institutions of higher education in those specific categories); for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments, as well as certain tribal organizations not otherwise classified as federally recognized tribal governments. The announcement also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws firm limits around foreign involvement: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in policy) are not allowed under this opportunity.

Administrative details in the source data indicate the sponsoring agency is the National Institutes of Health, with activity falling under education and health categories and CFDA/assistance listings including 93.395 and 93.839. The original closing date listed is October 2, 2023, and an award ceiling of $150,000 is shown in the provided record, though in practice applicants typically confirm current budget guidance and any per-site or per-component limits in the full NIH notice and related budget instructions for network awards. The overall intent remains consistent throughout: create a durable, well-coordinated national clinical trials network that can carry complex HCT and cell therapy studies from design through long-term follow-up, while also serving as a platform for additional trials funded through R01 collaborations, industry partnerships, and foundation support.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395, 93.839.
• This funding opportunity was created on 2023-06-20.
• Applicants must submit their applications by 2023-10-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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