Canine Cancer Immunotherapy Network (K9CIN; U01 Clinical Trial Not Allowed) | RFA CA 21 050

Opportunity Information: Apply for RFA CA 21 050

The Canine Cancer Immunotherapy Network (K9CIN) funding opportunity (RFA-CA-21-050) is a National Cancer Institute (NCI), NIH initiative designed to build a multi-site network that can run coordinated canine immuno-oncology studies in pet dogs that naturally develop cancer. The program focuses on spontaneous tumors in client-owned dogs, using these real-world cases to evaluate immunotherapeutic agents and novel combination regimens while also generating deep laboratory correlative data. The central idea is not only to test treatments, but to learn why some tumors respond and others do not by mapping the underlying cellular and molecular mechanisms that drive anti-tumor immunity, resistance, or non-response.

Awards are made as U01 cooperative agreements, meaning the funded projects are expected to operate in a highly collaborative, NCI-involved structure rather than as isolated investigator-driven studies. The intended outcome is a functioning network of canine clinical trial sites and partnered laboratories that can execute comparable protocols, generate harmonized datasets, and collectively answer immunotherapy mechanism questions faster than any single site could. Although the title includes "Clinical Trial Not Allowed," the FOA explicitly supports canine clinical studies in pet dogs; the restriction is tied to NIH human clinical trial policy categories, while the work itself is centered on veterinary clinical investigations paired with robust correlative science.

Scientifically, proposed studies must have a clear immunotherapy backbone. Each clinical study is required to either therapeutically modulate the tumor microenvironment (TME) or directly trigger immune-mediated destruction of cancer. This keeps the network tightly focused on immune mechanisms rather than general oncology drug testing. NCI signals several priority directions: combination strategies that pair immunotherapy or TME-modulating approaches with radiation therapy or other modalities (including targeted therapies, chemotherapies, or additional immunotherapies); adoptive cellular therapies such as CAR T-cell approaches or NK cell therapies; and trial designs that build in longitudinal tumor sampling. The FOA also highlights the value of modern molecular profiling, particularly tumor DNA sequencing and transcriptomics, to link treatment exposures to changes in tumor genetics, immune contexture, and gene expression programs over time.

A defining expectation of K9CIN is standardization and sharing across awardees. Participating groups are expected to share therapeutic agents when feasible, exchange specimens, and align laboratory and clinical protocols so results can be compared, validated, and aggregated across sites. This emphasis on harmonization is meant to reduce the usual fragmentation seen in multi-institutional veterinary studies and to ensure that correlative assays and clinical endpoints are collected in consistent, reproducible ways. The network model also implies that biospecimen handling, assay pipelines, and clinical data elements should be designed with cross-site integration in mind from the start, rather than retrofitted later.

The FOA is paired with a companion opportunity that funds a separate coordinating center under a U24 mechanism (referenced as RFA-CA-21-051). That coordinating center is intended to support the network by helping with protocol development and standardization, harmonization of clinical and laboratory operations, and shared infrastructure such as data management and statistical support. In practice, this means U01 sites are not operating alone; they are expected to plug into centralized coordination so studies, datasets, and operating procedures can be aligned and managed across the entire consortium.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument. It falls under health-related assistance listings (CFDA/Assistance Listing numbers 93.393, 93.394, 93.395). The original closing date listed is 2021-09-27, and the FOA was created on 2021-07-27. An explicit award ceiling and the expected number of awards are not specified in the provided source text.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city/township, and special district governments; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; public and private institutions of higher education; independent school districts; nonprofits with and without 501(c)(3) status; and for-profit organizations (other than small businesses) as well as small businesses. The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and eligible federal agencies. Foreign institutions and non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means certain well-justified collaborations or activities outside the U.S. can be included under a U.S. applicant institution when permitted by NIH policy.

Overall, K9CIN is structured to accelerate translational immuno-oncology by using naturally occurring canine cancers as a scientifically informative and clinically relevant setting. The network approach, the required focus on TME modulation or immune-mediated tumor killing, and the strong push toward longitudinal sampling and multi-omic profiling reflect an emphasis on mechanism-rich studies that can clarify why immunotherapies succeed or fail and help guide the next generation of combination strategies.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Canine Cancer Immunotherapy Network (K9CIN; 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): 93.393, 93.394, 93.395.
• This funding opportunity was created on 2021-07-27.
• Applicants must submit their applications by 2021-09-27. (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.

Apply for RFA CA 21 050

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