Opportunity Information: Apply for RFA DK 21 005
The National Institutes of Health (NIH) announced this discretionary grant opportunity, RFA-DK-21-005, titled "Immune Cell Engineering For Targeted Therapy And Disease Monitoring in Type 1 Diabetes (R01 Clinical Trial Not Allowed)." It uses the R01 research project grant mechanism and is focused on advancing next-generation immune cell engineering approaches that can home to, function within, and report from the human pancreatic environment. The core idea is to create engineered immune cells that do more than broadly modulate immunity: they are intended to specifically access the pancreatic compartment to reveal hard-to-measure details about how type 1 diabetes (T1D) starts and progresses, and to deliver therapeutic actions that respond to the local tissue context in ways that could protect or restore islet health and help prevent progression to overt disease.
Scientifically, the opportunity emphasizes two complementary goals. First, it seeks tools for disease monitoring by using engineered immune cells as living sensors that can enter pancreatic tissue and return information that is otherwise difficult to obtain in people, potentially enabling earlier detection of pathogenic processes and better tracking of disease stage or trajectory. Second, it supports therapeutic concepts in which engineered cells deliver "environment-specific" responses, meaning the cells could be designed to activate, secrete factors, or change behavior only under particular inflammatory or molecular conditions found in the pancreas during diabetes initiation or progression. This local, conditional activity is meant to improve precision and reduce off-target effects compared with systemic immune interventions, with the long-term aim of restoring islet function or preventing further immune-mediated damage that leads to T1D.
From an administrative and funding standpoint, this is an NIH grant in the health and nutrition/health research categories, associated with CFDA numbers 93.847 and 93.855. The award ceiling listed is $600,000, and the original closing date for applications was June 22, 2021, with a creation date of February 19, 2021. The notice specifies "Clinical Trial Not Allowed," which generally indicates applications should not propose a clinical trial as defined by NIH policy; the work is intended to be preclinical, mechanistic, or translational research that does not cross into conducting a clinical trial, even if it may ultimately inform future clinical studies.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. 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; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicant types. The announcement also calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); eligible federal government agencies; faith-based or community-based organizations; Hispanic-serving institutions; historically Black colleges and universities (HBCUs); Indian/Native American tribal governments other than federally recognized; regional organizations; tribally controlled colleges and universities (TCCUs); and U.S. territories or possessions.
Foreign participation rules are specific. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible. At the same time, the opportunity allows "foreign components" as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant may include certain well-justified elements of the project that take place outside the U.S. under NIH rules, even though a foreign institution cannot be the prime applicant.
In practical terms, this funding opportunity is aimed at multidisciplinary teams working at the intersection of immunology, bioengineering/synthetic biology, and diabetes research, with a clear emphasis on building engineered immune-cell platforms that can access the pancreas, generate informative readouts about disease processes, and execute targeted, context-dependent therapeutic functions. The intended payoff is both better visibility into the early and ongoing biology of T1D in the pancreatic compartment and more precise, locally tuned immune interventions that could help preserve or restore islet health before irreversible damage occurs.Apply for RFA DK 21 005
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Immune Cell Engineering For Targeted Therapy And Disease Monitoring in Type 1 Diabetes (R01 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): 93.847, 93.855.
- This funding opportunity was created on 2021-02-19.
- Applicants must submit their applications by 2021-06-22. (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 $600,000.00 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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Frequently Asked Questions (FAQs)
What is the official title and number of this NIH funding opportunity?
The opportunity is NIH RFA-DK-21-005, titled "Immune Cell Engineering For Targeted Therapy And Disease Monitoring in Type 1 Diabetes (R01 Clinical Trial Not Allowed)."
Which grant mechanism does this opportunity use?
This opportunity uses the NIH R01 Research Project Grant mechanism.
What is the overall purpose of this funding opportunity?
The purpose is to advance next-generation immune cell engineering approaches designed to home to, function within, and report from the human pancreatic environment in the context of type 1 diabetes (T1D). The emphasis is on engineered immune cells that can both reveal otherwise hard-to-measure details about T1D initiation and progression and potentially deliver targeted therapeutic actions within the pancreatic compartment.
What problem is this opportunity trying to solve in type 1 diabetes research?
The opportunity focuses on two linked challenges in T1D: (1) limited ability to directly observe and measure early and ongoing pathogenic processes in the human pancreas, and (2) the need for more precise, locally tuned immune interventions that can reduce off-target effects compared with broad systemic immune modulation.
What kinds of engineered immune cell capabilities are emphasized?
The announcement emphasizes immune cell engineering platforms that can:
- Access and home to the pancreatic compartment
- Function within the pancreatic tissue environment
- Report information back as "living sensors" for disease monitoring
- Deliver therapeutic responses that are conditional on local pancreatic inflammatory or molecular cues
What are the two main scientific goals supported by this RFA?
The RFA highlights two complementary goals:
- Disease monitoring: Using engineered immune cells as living sensors that can enter pancreatic tissue and return information that is difficult to obtain in people, with potential utility for earlier detection, staging, and tracking disease trajectory.
- Therapeutic concepts: Engineering immune cells to deliver environment-specific (context-dependent) responses within the pancreas, aiming to protect or restore islet health and help prevent progression to overt disease.
What does "engineered immune cells as living sensors" mean in this context?
It refers to engineered immune cells designed to enter pancreatic tissue and generate informative readouts about disease-related processes occurring in that compartment, returning insights that are otherwise hard to measure directly in humans.
What does "environment-specific" or "context-dependent" therapeutic activity mean?
It means engineered immune cells could be designed to activate, secrete factors, or alter behavior only when specific inflammatory or molecular conditions are present in the pancreas during T1D initiation or progression. The intent is to improve precision and reduce off-target effects compared with systemic interventions.
Is this opportunity intended to broadly modulate the immune system?
No. The core concept is to move beyond broad immune modulation by developing engineered immune cells that specifically access the pancreatic compartment, provide localized disease monitoring, and execute targeted actions that respond to the local tissue context.
Is a clinical trial allowed under this funding opportunity?
No. The notice specifies "R01 Clinical Trial Not Allowed," which generally means applications should not propose a clinical trial as defined by NIH policy.
If clinical trials are not allowed, what types of work does this opportunity support?
Based on the notice, the work is intended to be preclinical, mechanistic, or translational research that does not cross into conducting a clinical trial, even if it may inform future clinical studies.
What is the award ceiling for this opportunity?
The listed award ceiling is $600,000.
When was this funding opportunity created and when did it close?
The creation date is February 19, 2021, and the original closing date for applications was June 22, 2021.
Which NIH research area categories are associated with this opportunity?
The opportunity is described as an NIH grant in the health and nutrition/health research categories.
What CFDA numbers are associated with this grant?
The associated CFDA numbers are 93.847 and 93.855.
Who is eligible to apply as an applicant organization?
Eligibility is broad and includes many U.S.-based organizations and governmental entities, including:
- State governments; county governments; 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
- Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
- Other applicant types listed in the announcement
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The announcement specifically calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); faith-based or community-based organizations; Hispanic-serving institutions; historically Black colleges and universities (HBCUs); tribally controlled colleges and universities (TCCUs); and other listed entities.
Are U.S. territories or possessions eligible?
Yes. The announcement includes U.S. territories or possessions among eligible applicant types.
Can a foreign organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic foreign institutions are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. The opportunity states that non-domestic components of U.S. organizations are not eligible.
Are "foreign components" allowed at all?
Yes. The opportunity allows "foreign components" as defined in the NIH Grants Policy Statement. This typically means a U.S. applicant may include certain well-justified elements of the project that take place outside the U.S., consistent with NIH rules, even though a foreign institution cannot be the prime applicant.
What types of teams or expertise does this opportunity appear to be aimed at?
It is aimed at multidisciplinary teams working at the intersection of immunology, bioengineering/synthetic biology, and diabetes research, with a clear emphasis on engineered immune-cell platforms for pancreatic access, disease monitoring readouts, and targeted context-dependent therapeutic functions.
What is the long-term intended impact of projects funded under this RFA?
The intended payoff is improved visibility into early and ongoing T1D biology within the pancreatic compartment and the development of more precise, locally tuned immune interventions that could help preserve or restore islet health before irreversible damage occurs.
Does this opportunity focus on the human pancreatic environment specifically?
Yes. A central focus is developing engineered immune cells that can home to, function within, and report from the human pancreatic environment.
How does this opportunity aim to reduce off-target effects compared with systemic immune interventions?
By supporting engineered immune cells with local, conditional activity that is triggered only under particular pancreatic inflammatory or molecular conditions, the approach is intended to improve precision and reduce effects outside the target tissue compared with broad systemic immune modulation.
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