Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional) | RFA CA 22 022

Opportunity Information: Apply for RFA CA 22 022

This funding opportunity, RFA-CA-22-022 from the National Institutes of Health, supports early-stage, exploratory development work aimed at improving immuno-oncology research by building better cancer model systems. The central objective is to create or advance models that realistically reproduce human immunity within the tumor microenvironment so that preclinical immunotherapy studies are more predictive of what actually happens in patients. In practical terms, the NIH is looking for model platforms that more faithfully capture the complexity and behavior of the human immune system when it interacts with tumors, with the long-term payoff being stronger translational confidence when moving from lab findings into clinical testing.

A key requirement is that proposed models must recapitulate the human immune system using human cells or tissues. Projects are expected to regenerate and/or reproduce human immune components in either in vivo systems (for example, animal-based models) or in vitro systems (for example, organoids, co-culture platforms, microphysiological systems, or other engineered tumor-immune environments). The application needs to make clear how human immune lineage cells are introduced and sustained in the model, and how the resulting immune representation matches or surpasses what is achieved by murine models developed using HFT-based approaches (as referenced in the announcement). In other words, the bar is not simply "include some immune cells," but demonstrate a level of human immune complexity and relevance that competes with or improves upon advanced mouse-based humanized immune modeling methods.

The FOA is also explicit about what will not be considered responsive. Models that rely only on genetically manipulated immune systems without introducing human immune lineage cells do not meet the intent of the solicitation. That means a purely engineered or genetically altered host immune system, if it does not incorporate human immune cells or tissues, falls outside the scope. The NIH is emphasizing human immune reconstruction or representation, not just immune modulation through genetic edits.

From a funding mechanism standpoint, the opportunity is listed as a Cooperative Agreement, with a clinical trial designation of "optional." A cooperative agreement generally implies substantial NIH programmatic involvement during the project, such as coordination, milestone expectations, or active engagement to help steer development toward the program goals. While clinical trials are not required, they may be permitted if they fit the program rules and the proposed work justifies them. The FOA uses the R33 Exploratory/Developmental Grants Phase II activity code, which is commonly associated with later-stage exploratory development where proof-of-concept has been established and the goal is to further develop, validate, and position the technology or model for broader use.

Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic sectors. 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; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility signals an intent to attract diverse technical approaches and institutional capabilities, including international expertise where relevant.

The opportunity falls under NIH assistance listings tied to cancer research (CFDA/Assistance Listing numbers 93.393, 93.394, 93.395, 93.396, and 93.399). The original closing date listed in the source data is 2022-11-17, and the creation date is 2022-03-24. While the summary above captures the program purpose and responsiveness rules, applicants typically need to pay close attention to the full FOA for required milestones, data sharing expectations, model characterization standards, validation benchmarks, and any coordination requirements that come with the cooperative agreement structure.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396, 93.399.
• This funding opportunity was created on 2022-03-24.
• Applicants must submit their applications by 2022-11-17. (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 22 022

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: