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).

Applications for CLIN2 funding will be accepted four times a year, approximately on a quarterly basis. In 2026, application deadlines are currently planned for the last business day of the month, 2 PM (PT) for January, April, July, and October. Sign up for email alerts to stay up to date.

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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.

Download CLIN2 Program Announcement

Funding Area Preferences:

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).

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).

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:

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

Apply Here

CIRM Grants Policies, FAQs, and Primers

Clinical Development Resources

CLIN2 Application Resources

CLIN2 Informational Webinar Recording – Recorded May 30, 2025

CLIN2 Informational Webinar Slide Deck [PDF]

CLIN2 FAQs [PDF]

Watch webinar and Q&A

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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