Clinical Trial (CLIN2) Awards is a grant from the California Institute for Regenerative Medicine (CIRM) that funds the completion of Phase 1, 2, or 3 clinical trials for regenerative medicine and gene therapy treatments. CIRM's mission is to accelerate transformative stem cell and genetic therapies delivered equitably to patients, and the CLIN2 program provides major funding to advance promising therapies through clinical validation.

Eligible applicants include for-profit and nonprofit organizations with substantial operations in California. Awards range from $8 million to $15 million, with applications due April 30, 2026.

Clinical Trial (CLIN2) Awards – CIRM Information for Applicants Stem Cell and Genetic Research Information for Applicants Stem Cell and Genetic Research Clinical Trial (CLIN2) Awards Advancing Stem Cell and Gene Therapies CLIN2 applications are now closed.

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 The expected outcome of a CLIN2 award is completion of a single interventional clinical trial.

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.

California or non-California-based for-profit or non-profit organizations may apply. 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.

Download CLIN2 Program Announcement How to Submit an Application: 1. Go to the CIRM Grants Management Portal (grants. cirm.

ca. gov) 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.

2. After logging in, click on the Menu tab 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. 3.

Complete each section of the Application Click on the appropriate link and follow the instructions. Proposal templates can be located and submitted under the “Uploads” section. 4.

To submit your Application 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.

5. To confirm submission of 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.

CIRM Grants Policies, FAQs, and Primers Data Sharing and Management Requirements Access and Affordability Planning Requirements Allowable Costs and co-funding FAQ Commercialization Rights Primer (IP, Revenue Sharing, Pricing, Access, March-in Rights) Grants Administration Policy for Clinical Stage Projects FAQs on the Clinical Development (CLIN2) Program Qualification Process Clinical Development Resources Industry Resource Partner Program CIRM California Academic Cell and Gene Therapy Manufacturing Network CIRM Alpha Clinics Network CLIN2 Application Resources CLIN2 Informational Webinar Recording – Recorded May 30, 2025 CLIN2 Informational Webinar Slide Deck [PDF] 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. What is the award amount and duration? 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.

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 What types of projects are eligible for funding? 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). Can an investigator be included in more than one CLIN2 application? 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. Who can I contact with any questions about CLIN2?

Questions regarding this award should be emailed to clinical@cirm. ca. gov .

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