Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U01 Clinical Trial Not Allowed) | RFA AI 22 002

Opportunity Information: Apply for RFA AI 22 002

The National Institutes of Health (NIH) is soliciting applications under Funding Opportunity Number RFA-AI-22-002 for the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG). This is a discretionary health funding opportunity (CFDA 93.855) using the U01 cooperative agreement mechanism, meaning funded projects are expected to operate as a coordinated program with substantial NIH programmatic involvement rather than as fully independent investigator-initiated grants. The funding opportunity is explicitly labeled "Clinical Trial Not Allowed," indicating that the supported work must not include human clinical trials; the focus is on preclinical research and translational preparation using nonhuman primate (NHP) models.

The central purpose of the NHPCSG is to build and run a multi-center cooperative research program aimed at developing, optimizing, and rigorously evaluating strategies that can induce and maintain immune tolerance to allogeneic transplants in NHPs. In practical terms, the program is meant to help the field move beyond chronic immunosuppression by testing approaches that teach the recipient immune system to accept a transplanted organ or tissue from a genetically different donor without ongoing broad immune suppression. By using NHP models, the program targets a level of biological and immunological similarity to humans that is generally considered more predictive for transplantation outcomes than smaller-animal models, with the intention of reducing the risk and uncertainty when transitioning promising tolerance protocols toward clinical use.

The overarching goal is clinical translation, but through a preclinical pathway: generating the evidence, optimization steps, and comparative performance data needed to identify tolerance-induction protocols that are both effective and safe enough to justify future human testing in separate, appropriately designed clinical studies. This includes demonstrating long-term graft survival and durable immune tolerance, while also paying close attention to safety issues that can derail translation, such as infection risk, malignancy risk, off-target immune effects, graft-versus-host-like phenomena in certain settings, and other complications that may emerge when manipulating the immune system to achieve tolerance.

Because this is structured as a cooperative study group, applicants should expect an emphasis on collaboration across multiple centers, harmonized or comparable experimental designs where appropriate, shared standards for key endpoints and immunologic monitoring, and coordinated decision-making that supports the group mission. Cooperative programs like this typically value the ability to execute complex NHP transplantation studies with consistent quality, robust oversight, and the infrastructure needed for specialized assays, longitudinal follow-up, and cross-site data integration, all of which support the stated goal of producing results that are credible and usable for eventual clinical planning.

Eligibility is broad across U.S.-based organizational types. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other entities. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Foreign eligibility is restricted in a way that is common for NIH cooperative programs. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed. In effect, a U.S. applicant may be able to include certain foreign collaborations or activities as a component of the project when justified and allowable under NIH policy, but the primary applicant institution and its eligible components must be domestic.

Key administrative details provided in the source information include the agency (NIH), the original closing date (2022-05-13), and the creation date of the opportunity record (2022-01-18). The listing does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would typically need to consult the full RFA text for budget guidance, the anticipated scale of the program, and any institute- or program-specific expectations regarding the number of participating centers, required cores, or mandated governance structures.

In summary, this opportunity is designed to accelerate progress toward practical, clinically relevant transplantation tolerance by supporting a coordinated, multi-center set of NHP studies that can identify and refine tolerance-induction approaches with strong evidence for durable graft acceptance and acceptable safety, while operating under a cooperative agreement structure that prioritizes shared goals, alignment across participating sites, and NIH involvement in program coordination.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2022-01-18.
• Applicants must submit their applications by 2022-05-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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