CIRM CLIN2 Clinical Trial Awards

CIRM CLIN2 Clinical Trial Awards is sponsored by California Institute for Regenerative Medicine (CIRM). Supports Phase 1, 2, or 3 clinical trials for regenerative medicine therapies (stem cell or gene therapies) addressing unmet medical needs.

Clinical Trial (CLIN2) Awards – CIRM Clinical Trial (CLIN2) Awards Advancing Stem Cell and Gene Therapies CLIN2 applications are now open. Applications are due April 30, 2026, at 2 PM (PT).

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. 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 Funding Area Preferences: Program Preferences for fiscal year 2025-2026 For the 2025-26 fiscal year, if CIRM receives more than seven (7) CLIN2 applications that can be reviewed in a cycle, CIRM staff will prioritize applications that meet the following preferences: Develop pluripotent stem cell-derived therapies. Develop in vivo genetic therapies.

Develop therapies using non-viral nucleic acid delivery. Are projects addressing diseases of the brain and CNS.

A project is generally categorized as treating a disease or condition of the brain or central nervous system (CNS) if the therapeutic candidate is intended to primarily act upon and improve conditions involving aged, damaged, diseased, or defective tissues or impaired functionalities within the brain, spinal cord, retina, or optic nerve. Are applications from California organizations.

Are projects progressing from CIRM-funded IND-enabling or earlier phase clinical trial awards. For the purposes of CLIN2 preferences, a project is considered a direct progression when a prior CLIN2, CLIN1, PDEV, or TRAN award addressed the same indication with the same therapeutic, and the last activity or objective of that prior award aligns with the start of the current application.

For example, a CLIN1 or PDEV prior award that had a goal to achieve an active IND would directly progress to a CLIN2 award for a first-in-human trial, or a CLIN2 award to complete a first-in-human trial could progress to a phase II or subsequent phase I trial. Are projects with Fast Track, RMAT, or Breakthrough designations. Are projects proposing pivotal clinical trials (as agreed to by the FDA).

How Preferences are evaluated CIRM staff assigns one point for each of the preferences met, with an extra point being assigned for pivotal trials. The seven (7) applications with the highest preference scores proceed to full scientific review by the Grants Working Group (GWG).

If applications are tied for the seventh review position, the CIRM GWG will prioritize the tied applications based on the following value proposition criteria: The therapy’s potential to provide meaningful and substantial improvement in clinical outcomes for the intended population, compared with therapies currently available or in trials (e.g., efficacy, safety, patient burden).

The expected impact of addressing the unmet medical needs on patients, caregivers, and the healthcare system. The feasibility and practicality of the therapy’s uptake by patients, healthcare providers, and payors. If ties remain following the GWG value proposition scoring, CIRM staff will make final selections based on the representation of the disease area and therapeutic approach in CIRM’s clinical portfolio.

For Cycle 1 of CLIN2 (applications submitted June 30, 2025), CIRM received 23 applications. Five of these scored a 4 and went directly to GWG review. Two applications that scored a 3 advanced to full review after the GWG tie-breaking.

No second tie-break was needed. For Cycle 2 of CLIN2 (applications submitted October 31, 2025), CIRM received 21 applications. Four scored a 4 and went directly to GWG review.

Three applications that scored a 3 advanced after the GWG tie-breaking. No second tie-break was needed. Program Preferences for fiscal year 2025-2026 For the 2025-26 fiscal year, if CIRM receives more than seven (7) CLIN2 applications that can be reviewed in a cycle, CIRM staff will prioritize applications that meet the following preferences: Develop pluripotent stem cell-derived therapies.

Develop in vivo genetic therapies. Develop therapies using non-viral nucleic acid delivery. Are projects addressing diseases of the brain and CNS.

A project is generally categorized as treating a disease or condition of the brain or central nervous system (CNS) if the therapeutic candidate is intended to primarily act upon and improve conditions involving aged, damaged, diseased, or defective tissues or impaired functionalities within the brain, spinal cord, retina, or optic nerve. Are applications from California organizations.

Are projects progressing from CIRM-funded IND-enabling or earlier phase clinical trial awards. For the purposes of CLIN2 preferences, a project is considered a direct progression when a prior CLIN2, CLIN1, PDEV, or TRAN award addressed the same indication with the same therapeutic, and the last activity or objective of that prior award aligns with the start of the current application.

For example, a CLIN1 or PDEV prior award that had a goal to achieve an active IND would directly progress to a CLIN2 award for a first-in-human trial, or a CLIN2 award to complete a first-in-human trial could progress to a phase II or subsequent phase I trial. Are projects with Fast Track, RMAT, or Breakthrough designations. Are projects proposing pivotal clinical trials (as agreed to by the FDA).

How Preferences are evaluated CIRM staff assigns one point for each of the preferences met, with an extra point being assigned for pivotal trials. The seven (7) applications with the highest preference scores proceed to full scientific review by the Grants Working Group (GWG) .

If applications are tied for the seventh review position, the CIRM GWG will prioritize the tied applications based on the following value proposition criteria: The therapy’s potential to provide meaningful and substantial improvement in clinical outcomes for the intended population, compared with therapies currently available or in trials (e.g., efficacy, safety, patient burden).

The expected impact of addressing the unmet medical needs on patients, caregivers, and the healthcare system. The feasibility and practicality of the therapy’s uptake by patients, healthcare providers, and payors. If ties remain following the GWG value proposition scoring, CIRM staff will make final selections based on the representation of the disease area and therapeutic approach in CIRM’s clinical portfolio.

For Cycle 1 of CLIN2 (applications submitted June 30, 2025), CIRM received 23 applications. Five of these scored a 4 and went directly to GWG review. Two applications that scored a 3 advanced to full review after the GWG tie-breaking.

No second tie-break was needed. For Cycle 2 of CLIN2 (applications submitted October 31, 2025), CIRM received 21 applications. Four scored a 4 and went directly to GWG review.

Three applications that scored a 3 advanced after the GWG tie-breaking. No second tie-break was needed. How to Submit an Application: 1.

Go to the CIRM Grants Management Portal (grants. cirm. ca.

gov) 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.

CLIN2 applications are open. Applications are due by April 30, 2026, at 2 PM (PT).

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. 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 .