Key Dates

Related Announcements

None

Issued by

National Cancer Institute (NCI)

Purpose

In anticipation of a Cancer Adoptive Cellular Therapy (Can-ACT) Network from the recently published Funding Opportunity Announcements (RFA-CA-22-028, RFA-CA-22-029, RFA-CA-22-030), the National Cancer Institute (NCI) is seeking broad input and feedback on collecting critical clinical and mechanistic data elements for adoptive cellular therapy clinical trials for the treatment of adult and pediatric solid tumors. This request for information (RFI) is part of a planning effort designed to recognize the challenges in cell-based immunotherapy clinical trials data management with respect to data heterogeneity, harmonization, sharing, and reuse, with the purpose of identifying promising opportunities, and developing strategies for successfully collecting, analyzing, integrating and sharing of the Can-ACT clinical trials data and advancing novel cellular immunotherapy clinical testing.

Background

The Funding Opportunity Announcements (FOAs) for Cancer Adoptive Cellular Therapy (Can-ACT) Network for Adult (RFA-CA-22-028) and Pediatric Cancers (RFA-CA-22-029) seek to accelerate the development, innovation, and establishment of adoptive cellular therapy clinical trials for the treatment of adult and pediatric patients with solid tumors, and the Can-ACT Coordinating Center (RFA-CA-22-030) will oversee the management of network activities to facilitate multi-site clinical trials coordination and data collection, harmonization, quality, and sharing. The adoptive cell-based therapy (ACT) community has identified many needs for further development of cell-based strategies for solid tumors, including improved cell manufacturing approaches, studies of immune cell fitness/persistence, trafficking, and the tumor microenvironment, and support for small proof-of-concept multi-site clinical trials to rapidly gain knowledge of promising new treatment approaches. It is anticipated that each Can-ACT Network member will generate large, heterogenous data from their respective cellular therapy clinical trials and preclinical studies. The U24 Coordinating Center will support the Network efforts in developing data infrastructure, defining data types and elements, data collection and storage, data standardization, integration, sharing, and reuse. One of the goals of the Can-ACT Network is to enable broad sharing and utilization of findable, accessible, interoperable, reusable (FAIR) adoptive cellular therapy clinical and correlative data across the broad spectrum of immuno-oncology research and immunotherapy development. Challenges in achieving this goal include how to harmonize heterogenous, multi-dimensional data from different sources and how to best use the currently available, state-of-the-art platform/data infrastructure for data collection, reporting, analysis, sharing, and future reuse (particularly for clinical trials where regulatory considerations are needed). While there have been efforts in addressing such storage needs (such as the NCI Cancer Research Data Commons), there is still a considerable gap in creating a common data framework, or in modifying an existing system, for the storage of individual study/clinical trial data that will be generated by the new Can-ACT Network. Our goal is to provide an optimal framework for performing integration, analysis, reporting, and sharing Can-ACT data. At the same time, we wish to explore existing opportunities and thus desire to gather information on frameworks that may be adapted for use by the Network. In summary: this RFI intends to seek the opinions of the community on defining minimal data elements of patients clinical and immune characteristics as well as data elements to characterize the manufactured cell product. These attempts will enable NCI to effectively plan, design, harmonize, and manage the heterogenous data from the Can-ACT cellular therapy clinical trials for analysis, sharing, and reuse within the Network and by the large scientific community.

Information Requested

All stakeholders with an interest in improving the treatment of solid cancers through the application of cellular immunotherapy approaches are invited to provide information. Your response may mention your membership or affiliation within an industry, government, or academia.

NCI is seeking information that includes, but is not limited to, perspectives on the following areas:

• The core set of data types to capture early clinical trials of adoptive cell therapies and their correlative preclinical, clinical, and mechanistic studies on the cell product characteristics, efficacy, toxicity, and manufacturing information. Those data types may include phenotypic, genomic/proteomic, clinical, and demographic data, etc.
• The core set of data types to capture the history of patients treatment and the status of the immune system.
• Data types that are best shared in the raw vs. processed format (as data collection can be in raw or processed formats for storage and sharing).
• Data formats and their standardization for interoperability and multi-data integration.
• The minimum requirement of data elements in each data type for data reporting, sharing, and reuse.
• The common data elements (e.g., the fields that would be defined across a set of relational database tables) across heterogenous data types to allow data integration, analyses, and capability for answering relevant, complex basic and clinical questions.
• Software tools for modeling heterogenous data, mapping data elements, and integrating and sharing data.
• Use of centralized data warehouse vs. data federation for data storage, integration, and analyses.

Submitting a Response

All responses must be submitted electronically to NCIadoptivecelltherapy@mail.nih.gov by June 12, 2023. Please include the notice number "NOT-CA-23-042" in the subject line.

Response to this RFI is voluntary. Responders are free to address any or all the categories listed above. Please do not include any proprietary, classified, confidential, or sensitive information in your response.

All individual responses will remain confidential. Any identifiers (e.g., names, institutions, e-mail addresses, etc.) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with NIH staff members and members of scientific working groups convened by the NCI, as appropriate.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. The collected information will be reviewed by NIH staff, may appear in reports, and may be shared publicly on an NIH website.

The Government reserves the right to use any non-proprietary technical information in summaries of the state of science, and any resultant solicitation(s). The NIH may use the information gathered by this RFI to inform the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or individual NIH Institutes and Centers. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Zhang-Zhi Hu, M.D.
National Cancer Institute (NCI)
Telephone: 202-731-8819
Email: zhang-zhi.hu@nih.gov

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

Ronald Taylor, Ph.D.
National Cancer Institute (NCI)
Telephone: 509-783-7308
Email: ronald.taylor@nih.gov