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)

Key Dates

• August 24, 2022 - Cancer Adoptive Cellular Therapy Network (Can-ACT) for Adult Cancers (UG3/UH3 Clinical Trial Required). See NOFO RFA-CA-22-028.
• August 24, 2022 - Cancer Adoptive Cellular Therapy Network (Can-ACT) for Pediatric Cancers (UG3/UH3 Clinical Trial Required). See NOFO RFA-CA-22-029.
• August 24, 2022 - Cancer Adoptive Cellular Therapy Network (Can-ACT) Coordinating Center (U24 Clinical Trial Not Allowed). See NOFO RFA-CA-22-030.

National Cancer Institute (NCI)

The National Cancer Institute (NCI) intends to publish a Notice of Funding Opportunity (NOFO) soliciting UG3/UH3 applications for the pediatric arm of the Cancer Adoptive Cellular Therapy (Can-ACT) Network. The overall goal of the NOFO is to advance new cell therapy strategies into clinical testing for the treatment of solid tumors in pediatric cancer patients (18 years or younger). The successful applications will add to the newly established Cancer Adoptive Cellular Therapy (Can-ACT) Network, dedicated to developing innovative cell therapy approaches for the treatment of solid tumors in pediatric and adult tumors. This Network of investigators will, through novel and collaborative approaches to preclinical and translational studies, bring new cell therapy products into clinical trials.

This NOFO will solicit applications specifically for studies on pediatric cancer. NCI will not be soliciting applications for adult cancers or the U24 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 NOFO is expected to be published in January 2023 with an expected application due date in March 2024.

This Notice encourages investigators with expertise and insights into the area of cell therapy for the treatment of pediatric cancer to begin to consider applying for this new NOFO. Given the unmet clinical need, the scope of Can-ACT will be limited to investigating the treatment of solid tumors.

Awards made under this NOFO will initially support a two-year maximum, milestone-driven UG3 phase, with a possible transition to a clinical trial implementation phase (UH3) of up to three years duration. These applications must have at least 2 integrated objectives in the UG3 phase 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 in pediatric cancer. Only UG3 phase of the application that has met scientific milestones and feasibility requirements related to initiation of a clinical trial will be considered for transition to the UH3 phase.

The UG3/UH3 application must be submitted as a single application with the design of a sample UH3 clinical trial described in the application, following the instructions described in this FOA. The UG3 phase permits preclinical, translational, and IND-enabling studies. The UH3 phase must include initiation and conduct of an early phase, proof-of-concept, or first-in-human investigator-initiated, single-site, or multi-site clinical trial. Multi-center clinical trials conducted as part of Can-ACT UH3 awards will be eligible for support from 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 the Coordinating Center for the Can-ACT network.

Investigators have the opportunity and are encouraged to use the ICN Core for cell manufacturing in multi-center trials.

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
• Development of methods to measure 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 ACT clinical trials. The UG3/UH3 application must be submitted as a single application.

Non-responsive applications: This NOFO will not support:

• Applications that focus on adult tumor indications, unless a justification can be made for studying this in pediatric patients;
• Applications that focus on hematologic malignancies;
• Basic research and studies of disease mechanisms;
• Animal model development (all in vivo models must be well established, reproducible, and available to the applicant);
• Applications lacking an outline of a proposed clinical study protocol included with the submission (UH3 phase);
• Applications lacking milestones and go/no go decisions for the UG3 and UH3 phases; and
• Applications proposing Phase II/III registration trials.

These applications will be deemed not responsive to this NOFO and will not be reviewed.

Funding Information

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:

Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7303
Email: anju.singh@nih.gov

Kasia Bourcier, Ph.D.
National Cancer Institute (NCI)
Telephone: 202-657-7589
Email: bourcierkd@nih.gov