Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Adoptive Cellular Therapy Network (Can-ACT) for Adult Cancers (UG3/UH3 Clinical Trial Required)
Notice Number:
NOT-CA-22-074

Key Dates

Release Date:
April 11, 2022
Estimated Publication Date of Funding Opportunity Announcement:
July 29, 2022
First Estimated Application Due Date:
September 30, 2022
Earliest Estimated Award Date:
July 03, 2023
Earliest Estimated Start Date:
July 03, 2023
Related Announcements

NOT-CA-22-075 - Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Adoptive Cellular Therapy Network (Can-ACT) for Pediatric Cancers (UG3/UH3 Clinical Trial Required)

NOT-CA-22-076 - Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Adoptive Cellular Therapy Network (Can-ACT) Coordinating Center (U24 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) soliciting UG3/UH3 applications for the Cancer Adoptive Cellular Therapy (Can-ACT) Network. The goal of this collaborative research network will be to stimulate the conduct of early adoptive cellular therapy clinical trials for adult and pediatric solid tumors. The emphasis is on accelerating the advancement of new cell therapy strategies into clinical testing through novel and collaborative approaches to preclinical testing and translational studies. Can-ACT will support multi-investigator teams with the relevant expertise, assembled to bring new cell therapy products to the clinic.

This FOA is soliciting applications specifically for studies on adult cancers; a separate FOA will be released for projects focused on pediatric cancers. An additional FOA will also be released for a U24 award, which will support a Coordinating Center for the Can-ACT Network.

This notice is being provided to allow potential applicants sufficient time to develop a responsive grant application. The FOA is expected to be published in July 2022 with an expected application due date in September 2022. Details of a planned pre-application webinar will be announced in the Guide after publication of the FOA.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of cell therapy for the treatment of adult cancer to begin to consider applying for this new FOA. Given the unmet clinical need, the scope of Can-ACT will be limited to investigating the treatment of solid tumors. Awards made under the UG3/UH3 FOA will initially support a two-year milestone-driven planning phase (UG3), with a possible transition to an implementation phase (UH3). UG3 projects will address preclinical development research and studies needed for Investigational New Drug (IND) submission. These proposals must have at least 2 integrated projects that will advance a new cell therapy concept to clinical testing, while also conducting research to advance the understanding and clinical use of cell therapies. Examples of UG3 projects include but are not limited to advancements in:

  • Cell therapy genetic modifications;
  • Cell therapy manufacturing;
  • Modulation of the immunosuppressive tumor microenvironment;
  • Development of biomarkers to guide therapeutic use of cell therapies;
  • Development of imaging modalities to understand the trafficking of cells to tumor sites; and
  • Development of methods to measure the efficacy of cell therapies.

UG3 projects that have met the scientific milestone requirements may transition to the UH3 phase, which will include single-site or multi-site Adoptive Cellular Therapy (ACT) clinical trials. The UG3/UH3 application must be submitted as a single application.

Clinical trials conducted as part of Can-ACT UH3 awards will be supported by the Immune Cell Network Core Facility (ICN Core) at the Frederick National Laboratory for Cancer Research (FNLCR), which will provide GMP capabilities for molecularly modifying immune cells, producing vectors, and standardizing cell characterization assays for clinical testing, as well as supporting the collection and harmonization of multi-site clinical trial data. These efforts will be managed by a Coordinating Center for the Can-ACT network.

Funding Information

TBD

Estimated Total Funding

$3M in total costs

Expected Number of Awards

2

Estimated Award Ceiling

The budget for the two-year UG3 phase is limited to $0.675M in direct costs per year. The budget for the three-year UH3 phase is limited to $1.125M in direct costs per year.

Primary Assistance Listing Number(s)

93.395

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Kasia Bourcier, Ph.D.

National Cancer Institute (NCI)

202-657-7589

Zhang-Zhi Hu
National Cancer Institute (NCI)
Telephone: 240-276-6622
Email: zhang-zhi.hu@nih.gov