Clinical Trial Stage Projects

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CLIN2: Clinical Trial Stage Projects

Objective

The mission of California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs. With our Clinical Stage Programs, we intend to speed up support for clinical stage candidate stem cell treatments that demonstrate scientific excellence. Under this initiative, we will provide funding for eligible projects that are completing late stage preclinical development through any stage of clinical trial activity.

For our CLIN 2 Clinical Trial Stage Projects, the objective is to create a highly competitive partnering opportunity for promising stem cell-based projects to accelerate the completion of a clinical trial for a stem cell treatment that addresses an unmet medical need.

Under this program, CIRM will act not only as a funding agency, but will also devote significant internal resources and leverage its external team of world-class subject matter experts to actively advance the project. The result of a successful application will be the formation of a true partnership that both accelerates the program and gives it the greatest opportunity for success. 

Please see the Partnering Opportunity for Clinical Trial Stage projects for the Program Announcement, application deadline and other details. 


To Submit an Application:

  1. Go to the Grants Management Portal (https://grants.cirm.ca.gov) and log in with your existing CIRM Username and Password. If you do not have a Username, Click on 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“, click on the “Start a Grant Application” link for your selected program.
  3. Complete each section of the Application by clicking on the appropriate link and following the posted instructions. Proposal templates can be located and submitted under the “Uploads” section.
  4. To submit your Application, click on the “Done with Application” button. The “Done with Application” button will be enabled when all of the mandatory sections have been completed. Please note that once this has been selected, you will no longer be able to 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“. You will see your Application number and project title listed once the submission process has been completed.

ICOC Approval:
February 22, 2024
Total Awards:
85
Award Value:
$743,986,108

Awards

Institution Investigator Grant Title Award Value
Fate Therapeutics, Inc. Barbara Hickingbottom A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus $7,934,448
ImmPACT-Bio, Inc. DR Jonathan Benjamin A phase 1/2 study to evaluate a bispecific CD19/CD20-directed CAR T cell, in refractory lupus nephritis and systemic lupus erythematosus $8,000,000
Aspen Neuroscience Dr. Edward Wirth III Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease $8,000,000
Alto Neuroscience Amit Etkin A Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach $15,000,000
University of California, Davis Dr. Diana L. Farmer The CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele $8,996,477
Stanford University Dr. Reena Parada Thomas Phase I Trial of Locoregionally Delivered Autologous B7-H3 CAR T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme $11,999,991
City of Hope, Beckman Research Institute Elizabeth Budde Phase I Study of Chimeric Antigen Receptor Engineered T Cells targeting CD33 for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia $11,983,547
University of California, San Diego Olivia Kim-McManus Personalized antisense oligonucleotide therapy for rare pediatric genetic disease: SCN2A $985,713
Stanford University Anusha Kalbasi Stem-Derived IL13Ra2 Chimeric Antigen Receptor T cells for Patients with Melanoma and Advanced Solid Tumors $10,211,085
Regenerative Patch Technologies LLC Dr Jane S Lebkowski A Phase 2b, Randomized, Assessor-Masked Clinical Trial to Assess the Safety and Efficacy of the CPCB-RPE1 Implant in Subjects with Geographic Atrophy $12,373,748
City of Hope, Beckman Research Institute Dr. Angelo Manuel Almeida Cardoso Ph.D., MD Evaluation of Safety and Feasibility of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV/HIV-CAR) T Cells in People with HIV $11,299,976
Combangio, Inc. R. Kim Brazzell Phase 2b Clinical Study of KPI-012 Topical Ophthalmic Human Mesenchymal Stem Cell Secretome for the Treatment of Persistent Corneal Epithelial Defect $15,000,000
Immusoft Corporation Dr Robert Hayes A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Patients with Mucopolysaccharidosis Type 1 $8,000,000
Eureka Therapeutics, Inc. Pei Wang Autologous ARTEMIS® T Cells to Treat Refractory/Relapsed Pediatric Liver Cancer $10,600,072
Stanford University Dr. Matthew H Porteus Reduced intensity conditioning with JSP191 prior to TCRαβ+ T-cell/CD19+ B-cell depleted hematopoietic stem cell transplant for Fanconi Anemia patients $10,642,420
Angiocrine Bioscience, Inc. Dr. Paul Finnegan AB-205-301 Phase 3 Trial and Related Activities to Support Clinical Development of AB-205 $15,000,000
Genascence Corporation Dr. Thomas W Chalberg Jr. A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Ranging Study of GNSC-001 Evaluating Safety, Pharmacodynamics, and Biomarkers in Knee OA $11,637,194
Tachyon Therapeutics, Inc Ivan King TACH101: A Potent, First-In-Class KDM4 Inhibitor for Advanced Cancers $6,862,609
City of Hope, Beckman Research Institute Ryotaro Nakamura Treatment of Severe Aplastic Anemia by induction of mixed chimerism using CD4+ T cell depleted haploidentical donor stem cell transplant $9,054,216
Stanford University Alice Bertaina Sequential same donor αβdepleted-HSCT from an HLA-partially matched donor allowing immunosuppression free kidney transplant $11,998,188
Neurona Therapeutics Dr. Cory R Nicholas Phase 1/2 Study of NRTX-1001 Neural Cell Therapy in Subjects with Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy $7,999,999
Excision BioTherapeutics William Kennedy Phase 1 Clinical research program for functional cure of HIV with EBT-101, in-vivo gene therapy $6,852,486
Wake Forest University Health Sciences James Yoo Phase I Treatment of Urethral Strictures in Humans $3,841,593
Stanford University Dr. Rosa Bacchetta Phase 1 Study of Autologous CD4LVFOXP3 in Participants with IPEX Syndrome $11,999,179
City of Hope, Beckman Research Institute Dr Jana Portnow A Phase I Study of Multiple doses of NSC-Based Oncolytic Virotherapy Administered Intracerebrally to Patients with Recurrent High-Grade Gliomas $11,999,984
University of California, Davis Peter C Belafsky A Double-Blind Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Progenitor Cells for the Treatment of Dysphagia $11,015,936
BioEclipse Therapeutics INC. Dr. Pamela Reilly Contag PHASE 1, OPEN LABEL, DOSE-ESCALATION STUDY OF CRX100 IN PATIENTS WITH ADVANCED SOLID TUMORS $7,999,689
Stanford University Dr. Joseph C. Wu A Phase I, Pilot Study of Human Embryonic Stem Cell-Derived Cardiomyocytes in PaTients with ChrOnic Ischemic Left VentRicular Dysfunction (HECTOR) $6,987,507
Stanford University Crystal Mackall Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor T Cells for Diffuse Intrinsic Pontine Gliomas and Spinal Diffuse Midline Glioma $11,998,310
Stanford University Dr. Matthew H Porteus Phase 1/1b study of T-allo10 infusion after HLA-partially matched abdepleted-HSCT in children and young adults with hematologic malignancies. $10,563,822
Stanford University Dr. Gary Steinberg Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke $11,998,988
Cedars-Sinai Medical Center Clive Svendsen CNS10-NPC-GDNF delivered into the motor cortex for the treatment of ALS $11,990,372
City of Hope, Beckman Research Institute Dr. Leo D Wang Phase I Study of IL13Rα2-Targeting CAR T Cells After Lymphodepletion for Children with Refractory or Recurrent Malignant Brain Tumors $8,401,309
Immune-Onc Therapeutics Joseph Paul Woodard Phase 1 Clinical Development of IO-202, A First-in-Class Antibody Targeting LILRB4, for the Treatment of AML with Monocytic Differentiation and CMML $6,000,000
University of California, Davis Dr. Diana L. Farmer The CuRe Trial: Cellular Therapy for In Utero Myelomeningocele Repair $8,996,474
Rocket Pharmaceuticals, Inc. Dr. Gayatri Rao A Phase I Clinical Trial for a Lentiviral Gene Therapy Targeting the TCIRG1 Gene for Infantile Malignant Osteopetrosis (IMO) $1,010,000
University of California, San Francisco Steven G. Deeks Anti-HIV duoCAR-T cell therapy for HIV infection $8,970,732
Brain Neurotherapy Bio Krystof S. Bankiewicz A Phase 1b Safety Study for MRI guided delivery of AAV2-GDNF for the treatment of Parkinson’s disease $5,510,462
University of California, Los Angeles Dr. Sophie X Deng Safety and Feasibility of Cultivated Autologous Limbal Stem Cells for Limbal Stem Cell Deficiency $10,301,486
Cedars-Sinai Medical Center Clive Svendsen Clinical Study to Assess Safety and Efficacy of Subretinal Injection of Human Neural Progenitor Cells for Treatment of Retinitis Pigmentosa $10,444,063
City of Hope, Beckman Research Institute Dr Saul J Priceman A Phase I Study of Chimeric Antigen Receptor Engineered Stem/Memory T Cells for the Treatment of HER2-Positive Brain Metastases $9,015,149
Rocket Pharmaceuticals, Inc. Dr. Kinnari Patel LADICell $5,867,085
University of California, San Diego Dr. Stephanie Cherqui Phase 1/2 study for autologous human CD34+ hematopoietic stem cells ex vivo transduced with pCCL-CTNS lentiviral vector for treatment of Cystinosis. $11,999,944
jCyte, Inc Henry John Klassen A Phase 2 Study of the Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects with Retinitis Pigmentosa $6,608,592
University of California, San Francisco Peter Stock Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Diabetes in the Intra-Muscular Site: PARADIGM $11,083,012
Jasper Therapeutics, Inc. Wendy Pang A monoclonal antibody that depletes blood stem cells and enables chemotherapy free transplants $2,313,398
Stanford University Dr. Judith A Shizuru A monoclonal antibody that depletes blood stem cells and enables chemotherapy free transplants $1,113,487
Stanford University Dr. Everett H. Meyer Induction of Tolerance by Combinatorial Therapy w/ Donor Stem Cells and Expanded Recipient Treg cells in HLA-mismatched Kidney Transplant Recipients $11,955,585
University of California, Los Angeles Theodore Scott Nowicki Genetic Modification of Stem Cells and T cells to Activate the Immune System to Target Solid Tumors $4,230,000
Angiocrine Bioscience, Inc. Dr. Edward Kavalerchik AB-205-001 Phase 1b Trial and Related Activities to Support Clinical Development of AB-205 $6,192,579
Sangamo BioSciences, Inc. Bettina Cockroft A Phase 1/2 Study to Assess the Safety, Tolerability, and Efficacy of ST-400 Autologous HSPC Transplant in Transfusion-dependent β-Thalassemia $5,150,000
City of Hope, Beckman Research Institute Dr. De-Fu Zeng Treatment of sickle cell disease by induction of mixed chimerism and immune tolerance using CD4+ T-depleted haploidentical blood stem cell transplant $4,352,180
Stanford University Dr. David B. Miklos Phase 1 Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies $11,034,982
University of California, San Francisco Mort Cowan Gene Transfer for Artemis-Deficient Severe Combined Immunodeficiency Using a Lentiviral Vector to Transduce Autologous CD34 Hematopoietic Stem Cells $12,000,000
University of California, Los Angeles Steven M. Dubinett A phase I trial of intratumoral administration of CCL21-gene modified dendritic cell (DC) combined with intravenous pembrolizumab for advanced NSCLC $10,955,315
Medeor Therapeutics, Inc. Daniel Brennan Cellular Immunotherapy for Induction of Immune Tolerance in HLA Matched Living Donor Kidney Transplant Recipients $11,217,155
Poseida Therapeutics, Inc. Rajesh Belani MD Clinical Study of T stem cell memory (Tscm)-based CAR-T cells in Patients with Multiple Myeloma $19,813,407
Children’s Hospital of Los Angeles Michael A. Pulsipher Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) $4,825,587
Calibr Dr. Kristen A Johnson Evaluation of the Safety and Tolerability of KA34 in a Phase 1, Double-Blind, Dose Escalation Trial in Patients with Knee Osteoarthritis $8,447,523
Angiocrine Bioscience, Inc. Dr. Edward Kavalerchik AB-110-001 Phase 1b Trial and Related Activities to Support Clinical Development of AB-110 $5,000,000
SanBio, Inc. Dr. Bijan Nejadnik A Double-Blind, Controlled Ph 2b Study of the Safety and Efficacy of Modified Stem Cells in Patients with Chronic Motor Deficit from Ischemic Stroke $18,970,000
City of Hope, Beckman Research Institute Dr. Christine E. Brown Phase I Study of Chimeric Antigen Receptor Engineered Central Memory T cells for the Treatment of Malignant Glioma $12,753,854
University of California, San Diego Thomas J Kipps A Phase 1b/2a Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab, and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in B-Cell Cancers $18,292,674
Forty Seven Inc. Mark Chao Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination with Azacitidine in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome $0
BrainStorm Cell Therapeutics Dr. Ralph Kern A Phase 3, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy & Safety of Repeated Administrations of NurOwn® in Patients with ALS $15,912,390
Caladrius Biosciences Dr. William Sietsema Phase 2 Safety and Efficacy Study of CLBS03 Autologous T-Regulatory Cells in Adolescents with Recent Onset Type 1 Diabetes Mellitus $8,175,946
jCyte, Inc Henry John Klassen Phase 2b Clinical Study of Safety and Efficacy of Intravitreal Injection of Retinal Progenitor Cells (jCell) for Treatment of Retinitis Pigmentosa $8,295,750
Humacyte, Inc. Jeffrey Lawson A Phase 3 Study Comparing the Utility of Human Acellular Vessels to Arteriovenous Fistula in Subjects with End-Stage Renal Disease (California Sites) $3,525,000
ViaCyte, Inc. Manasi Jaiman Clinical trial of directly vascularized islet cell replacement therapy for high-risk type 1 diabetes $13,607,002
Forty Seven Inc. Mark Chao A Phase 1b/2 Trial of the Anti-CD47 Antibody Hu5F9-G4 in Combination with Cetuximab in Patients with Solid Tumors and Advanced Colorectal Cancer $0
Nohla Therapeutics Inc Dr. Colleen Delaney A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Optimal Dose-Finding Study of DCC-UCB in Adults Receiving High Dose Chemotherapy for AML $4,310,000
St. Jude Children’s Research Hospital Stephen Gottschalk Lentiviral Gene Therapy for Infants with X-linked Severe Combined Immunodeficiency using Autologous Bone Marrow Stem Cells and Busulfan Conditioning $11,924,780
Cedars-Sinai Medical Center Dr. Michael I Lewis Pulmonary Arterial Hypertension Treated with Cardiosphere-Derived Allogeneic Stem Cells $7,354,772
Stanford University Dr Robert Lowsky Induction of Tolerance to Combined Kidney and Hematopoietic Progenitor Cell Transplants from HLA Haplotype Matched Living Donors $6,653,266
University of California, Los Angeles Dr. Donald B. Kohn Efficacy and safety of cryopreserved autologous CD34+ HSC transduced with EFS lentiviral vector encoding for human ADA gene in ADA-SCID subjects $5,827,000
Orchard Therapeutics plc Leslie Meltzer Efficacy and safety of cryopreserved autologous CD34+ HSC transduced with EFS lentiviral vector encoding for human ADA gene in ADA-SCID subjects $2,638,745
University of California, Los Angeles Dr. Donald B Kohn Efficacy and safety of cryopreserved autologous CD34+ HSC transduced with EFS lentiviral vector encoding for human ADA gene in ADA-SCID subjects $10,156,925
Cedars-Sinai Medical Center Professor Clive N Svendsen Human Neural Progenitors Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral Sclerosis $6,154,067
University of California, San Francisco Dr. Tippi C. Mackenzie MD In Utero Hematopoietic Stem Cell Transplantation For The Treatment Of Fetuses With Alpha Thalassemia Major $10,906,978
Humacyte, Inc. Jeffrey Lawson A Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY) $7,625,000
Capricor, Inc Dr. Linda Marban Allogeneic Cardiosphere-Derived Cells for Duchenne Muscular Dystrophy Cardiomyopathy $3,376,259
University of California, Davis Dr Mehrdad Abedi Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-selected CD34+ Cells in AIDS lymphoma patients $8,414,265
ImmunoCellular Therapeutics Anthony J. Gringeri A Phase III randomized double-blind, controlled study of ICT 107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy $5,391,016
Caladrius Biosciences Robert Dillman Tumor stem cell-targeted immunotherapy for metastatic melanoma –a randomized phase 3 clinical trial. $3,000,000
University of California, Los Angeles Dr. Donald B. Kohn A Phase I/II, Non Randomized, Multicenter, Open-Label Study of G1XCGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease $7,083,364
Total:
$743,986,107.59