CRI Clinical Innovator

Advancing Breakthrough Immunotherapy Trials to Transform Patient Care

The CRI Clinical Innovator supports pioneering immunotherapy clinical trials designed and led by academic researchers. These investigator-initiated studies are vital to improving patient outcomes, addressing areas of high unmet need, and generating critical mechanistic insights that can guide the future of cancer treatment.

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The CRI Clinical Innovator funds innovative phase I/II or phase II clinical studies with a strong emphasis on:

• Novel immunotherapy approaches
• Mechanistic investigations into clinical response
• The discovery and/or validation of predictive biomarkers

In an effort to maximize impact and ensure translational rigor, CRI may provide strategic guidance on trial design. CRI encourages data sharing through platforms such as the CRI iATLAS. 

Applications are evaluated based on novelty, feasibility, scientific rationale, and potential for clinical impact. Competitive studies will integrate standardized approaches to sample collection, correlative assays, and advanced data analyses, ensuring that findings are reproducible, shareable, and impactful across the field. 

By supporting clinician-scientists at the forefront of immunotherapy, the Clinical Innovator program advances clinical research that not only tests new therapies, but also deepens our understanding of the immune system’s role in cancer.

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In partnership with the Chordoma Foundation (CF), CRI also invites proposals focused on accelerating the development of effective treatments and ultimately a cure for chordoma, a rare type of cancer that occurs in the bones of the skull base and spine. Please be advised that CF has chordoma models and banked tumor samples (including a new TMA consisting of 95 chordoma specimens) that are available to the research community.  Successful applications in this area will be co-funded by CRI and CF.

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The Clinical Innovator provides up to $1M per trial. Funding may be used for investigator salary, patient costs, supplies, correlative assays, and data analyses. Payments are structured in milestones to ensure steady progress and trial completion.

Institutions will be provided indirect costs of up to 10% of the total amount awarded. Indirects are provided in addition to awarded funds.

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Candidates must be the Principal Investigator (PI) of the proposed study. CRI has no citizenship restrictions, and research supported by the award may be conducted at medical schools or research centers in the United States or abroad. Please note that CRI does not support research at for-profit institutions.

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The deadline to submit an Initial Protocol Concept is December 1. Candidates will be notified by late February if they are invited to submit a full proposal, including protocol. 

Invited applications are due April 4. If these deadlines fall on the weekend, proposals will be accepted until the end of day that following Monday.

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An initial Protocol Concept must be submitted electronically using the CRI online submission portal. If this is the first time you are submitting a grant application to CRI, you will be asked to create a new user account to catalog all applications you submit to CRI.

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The Initial Protocol Concept must include:

• A brief protocol concept (maximum 2 pages, excluding study schema and references) including:

  – Study rationale

  – Primary objectives 

  – Secondary objectives

  – Number of patients to be treated

  – Patient eligibility criteria

  – Sample collection plan

  – Biostatistics plan
• A separate 1-page study schema should be uploaded outlining the clinical design.
• A brief translational plan (maximum 1 page, excluding references)

  – Translational aims and rationale 

  – Assays intended to use and samples to be tested
• Biographical sketches for PI(s) and co-PI(s) (limit bibliography to past 5 years or publications relevant to proposed study)

Notes:

• Only PDF documents will be accepted. All files must be submitted individually on the attachments page of the online application.
• When you have finished uploading the attachments, click “Submit.” You will receive a notice confirming that you have successfully submitted your Application Form. Immediately after, an automated notification from CRI will be sent to your email address, also confirming submission. If you encounter problems uploading your attachments, email them to [email protected]. Be sure to note the application number, which will be assigned to you at the time of submission.
• Online applications will be accepted until 11:59 p.m. Eastern Time on the deadline date. If the deadline falls on the weekend, applications will be accepted until the end of day that following Monday. We strongly suggest submitting your applications as early as possible to provide ample time in case your application is incomplete. Incomplete applications will not be considered.
• Formatting Guidelines: Any documents you attach to your online application form must be typed single-space using a 12 point or larger font size.