Cancer Adoptive Cellular Therapy Network (Can-ACT) for Pediatric Cancers (UG3/UH3 Clinical Trial Required) | RFA CA 24 021

Opportunity Information: Apply for RFA CA 24 021

The Cancer Adoptive Cellular Therapy Network (Can-ACT) for Pediatric Cancers (UG3/UH3 Clinical Trial Required) is a National Cancer Institute (NCI), NIH funding opportunity designed to speed the development and early clinical testing of new adoptive cellular therapies for children with solid tumors. The program focuses specifically on pediatric cancer patients age 18 and under, with an explicit goal of moving promising cell therapy concepts out of the lab and into clinical trials more efficiently. Rather than supporting isolated projects, NCI is building a coordinated network (the pediatric arm of the broader Can-ACT Network) where multiple investigators and complementary skill sets are brought together to solve the scientific, translational, and operational barriers that often slow cell therapy progress in solid tumors.

This opportunity uses the UG3/UH3 phased cooperative agreement structure, which is commonly used by NIH when they want both milestone-driven development work and a clear, supported transition into a later-stage implementation phase. In practical terms, applicants should expect a two-stage pathway: an initial UG3 phase intended to finalize and de-risk key steps needed to launch a trial (for example, completing critical preclinical validation, manufacturing readiness, product characterization, assay development, and other translational requirements), followed by a UH3 phase that supports execution of the clinical trial once specific go/no-go milestones are met. The title indicates that a clinical trial is required, meaning proposed projects are expected to culminate in, and include, clinical testing rather than stopping at preclinical development. Because this is a cooperative agreement, awardees should also expect substantial programmatic involvement from NCI, including coordinated planning, milestone oversight, and network-based collaboration.

Scientifically, the emphasis is on adoptive cellular therapy strategies aimed at pediatric solid tumors, an area where progress has been harder than in some blood cancers due to issues like tumor antigen heterogeneity, immunosuppressive tumor microenvironments, trafficking and persistence challenges, and safety concerns when targeting antigens shared with healthy tissues. The NOFO is framed to encourage innovative and collaborative approaches to preclinical testing and translational studies that make it more likely a candidate cell therapy product can reach clinical testing quickly and safely. While the summary does not list specific cell therapy modalities, the scope implied by “adoptive cellular therapy” typically includes engineered and non-engineered immune cell products (for example, CAR-T or CAR-NK concepts, tumor-infiltrating lymphocyte approaches, TCR-engineered T cells, or other engineered immune effector platforms), provided the work is positioned to enter clinical evaluation for pediatric solid tumors.

A central feature of the opportunity is the expectation of multi-investigator, team-based proposals. NCI is looking for groups that collectively cover the full development-to-clinic chain: discovery and translational science, relevant tumor biology, immune engineering, product manufacturing and quality systems, clinical trial design and conduct, correlative science and biomarker development, and regulatory readiness. The network model is meant to avoid the common failure mode where strong lab ideas stall because manufacturing, safety testing, trial operations, or regulatory planning are under-resourced or disconnected. By adding successful pediatric-focused projects into the already established Can-ACT Network, NCI is aiming to create shared standards, shared learning across teams, and faster iteration toward clinically actionable therapies.

From an administrative standpoint, the opportunity is a discretionary NIH cooperative agreement in the health area (CFDA 93.395) with the funding opportunity number RFA-CA-24-021. The original application due date listed is 2024-03-06, and the listed award ceiling is $900,000. The expected number of awards is not specified in the provided text, which typically means applicants should not assume a particular award count and should treat the competition as potentially selective. Because NIH awards and budgets can be complex (often involving direct and indirect cost structures and multi-year commitments), applicants generally need to align their budget with the phased UG3/UH3 plan and the milestones that trigger transition from the planning/de-risking stage to the clinical execution stage.

Eligibility is broad and includes many U.S.-based organizational types: 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 that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The opportunity also explicitly highlights a range of other eligible applicant categories often emphasized by NIH to broaden participation, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribal Colleges and Universities, and faith-based or community-based organizations, among others. At the same time, the restrictions on foreign participation are clear: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. In short, the work and the applying organization must be U.S.-based without foreign components under NIH definitions.

Overall, this NOFO is best understood as NCI investing in a coordinated pediatric cell therapy pipeline for solid tumors: building interdisciplinary teams, insisting on a clinically testable endpoint, and using milestone-driven cooperative agreements to keep projects moving toward real-world evaluation in children. The practical takeaway for potential applicants is that proposals need to be credible end-to-end translational plans, not just compelling biology. The strongest applications are likely to be those that can show a realistic path to manufacturing and regulatory readiness, a well-justified first-in-child or pediatric-focused trial concept, thoughtful safety and monitoring plans, and robust correlative studies that will generate interpretable data to guide next iterations of pediatric solid tumor cell therapy.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cancer Adoptive Cellular Therapy Network (Can-ACT) for Pediatric Cancers (UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
• This funding opportunity was created on 2023-12-06.
• Applicants must submit their applications by 2024-03-06. (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 $900,000.00 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.

Apply for RFA CA 24 021

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