Clinical Trial (CLIN2) Awards
Advancing Stem Cell and Gene Therapies
CLIN2 Award application period opens May 22, 2025
Applications are due by June 30, 2025
Photo Credit: Barbara Ries of UCSF
Clinical Programs at CIRM
The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.
CIRM’s CLIN2 funding program will support the completion of phase 1, 2, or 3 clinical trials— including pivotal trials— for regenerative medicine therapies that address significant unmet medical needs and have the potential to provide transformative benefits to patients, their families, and the healthcare system. Through this program, CIRM creates funding opportunities for regenerative medicine clinical research that otherwise do not exist or are of limited scope. CIRM will devote internal resources and leverage a network of world-class subject matter experts to help ensure that funded projects have a comprehensive clinical development strategy aimed at obtaining marketing approval with a well-developed plan for ensuring access and affordability.
CLIN2 Awards: Key Information
Expected Outcomes
The expected outcome of a CLIN2 award is completion of a single interventional clinical trial.
Award Amount & Duration
The award amount ranges from $8 million to $15 million and is dependent on the stage of the clinical trial and the for-profit versus non-profit status of the applicant organization. Projects may have a maximum planned duration of four years.
See the Program Announcement for more details.
Project Eligibility
California or non-California-based for-profit or non-profit organizations may apply.
Funding Allocation
CIRM anticipates funding between 9-16 CLIN2 awards in fiscal year 2025-2026, contingent on the number of applications at each funding level that are recommended.
Download the CLIN2 Program Announcement (PA) for more information on award eligibility, review criteria, and the application process.
How to Submit an Application:
Log in with your existing CIRM username and password. If you do not have a username, click the “New User” link and follow the instructions to create a CIRM username and password.
Select the tab labeled “Open Programs” under the section labeled “RFAs and Programs Open for Applications,” and click on the “Start a Grant Application” link for the selected program.
Click on the appropriate link and follow the instructions. Proposal templates can be located and submitted under the “Uploads” section.
Click on the “Done with Application” button. After completing all the mandatory sections, the “Done with Application” button will be enabled.
Note: Once submitted, you can no longer make changes to your application.
Select the tab labeled “Your Applications” and check the table under the section labeled “Your Submitted Applications.” Once the submission process has been completed, you will see your application number and project title listed.
CLIN2 Award application period opens May 22, 2025. Application deadline is June 30, 2025.
CIRM Grants Policies, FAQs, and Primers
CLIN2 Application Resources
CIRM will host a live informational webinar and Q&A session on May 30, 2025 at 2:30 PM (PST).
CIRM Clinical Program Funding Opportunity: CLIN2 Award. This webinar provides an opportunity for prospective applicants to learn about CIRM’s updated CLIN2 Funding Opportunity and how to assemble a competitive application. CIRM team members will share information on award scope and structure, preference topics, and the submission process.
CLIN2 FAQs
This funding opportunity is open to both non-profit and for-profit organizations that may either be based in California or outside of California. Non-California applicants may only request funding for clinical and non-clinical research activities that are directly attributable to treatment of California subjects and allowable costs for manufacturing that is to be conducted in California.
- The award cap is dependent on the proposed trial phase and non-profit vs. for-profit status of the applicant. For first in human phase 1 trials, non-profit applicants may request up to $12 million total costs, inclusive of direct, facilities and indirect costs. For-profit applicants or non-profit applicants with for-profit partners may request up to $8 million total costs. Both non-profit and for-profit applicants may request up to $15 million total costs for all other trial phases (phase 1 subsequent to a previous first in human, phase 2 and phase 3).
- The maximum duration of a CLIN2 award is four years.
- Co-funding is required for some awards, and the level of co-funding is dependent on the proposed trial phase and non-profit vs. for-profit status of the applicant organization. In addition, for awards that propose manufacturing for the next phase trial, that activity requires 50% co-funding if the overall award has any co-funding requirement. Please see table below and refer to the PA for further details.
Co-funding Requirement:
- First in Human: 30% (for-profit*); None (non-profit)
- Phase 2 or Subsequent: 50% (for-profit); None (non-profit)
- Phase 3 or pivotal: 50% (for either profit or non-profit)
- Manufacturing for next trial: 50%, if overall award has a co-funding requirement
- Applicants may request funds for an interventional phase 1, 2 or 3 trial for a stem cell-based or genetic therapy. In addition to the interventional trial, the program may also support a lead-in normal healthy volunteer study or natural history study that is needed for baseline or control data for the interventional trial.
- See CIRM Funding Opportunities: Common Requirements and Definitions for the CIRM definitions of stem cell-based or genetic therapies. Proposals must satisfy all other eligibility requirements listed in the latest version of the CLIN2 Program Announcement (Coming Soon).
- The principal investigator may not apply for more than one CLIN2 award within the same funding cycle.
- There are no other restrictions on CIRM applications by principal investigators. The same individual may be named as key personnel on multiple CLIN2 applications, including those submitted within the same funding cycle.
Questions regarding this award should be emailed to clinical@cirm.ca.gov.
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