Project Objective: Clinical Trial, Phase 1 or Phase 1/2


University of California, San Francisco (UCSF) Alpha Stem Cell Clinic (ASCC)

We propose cell and gene therapy trial infrastructure that will focus on hereditary hematological and immunologic disorders and on anti-inflammatory lung disorders. This alpha stem cell clinic operation at UCSF will expand access to these novel cell and gene therapies to California citizens . The objective of this proposal from the Univ. of Calif., San […]

The Stanford Alpha Stem Cell Clinic

Our project objective is to develop a sustainable infrastructure and become a Northern California hub for stem cell therapies, thus both reducing current patient burden and increasing access to this treatment modality for patients with unmet medical needs. A major roadblock in stem cell therapies is confirming their efficacy in patients. The Alpha Clinic will […]

University of California, San Francisco (UCSF) CIRM Alpha Stem Cell Clinic

We propose a cellular trial operation at UCSF that will focus on childhood hereditary hematological and immunologic disorders and in anti-inflammatory lung cellular therapies. This alpha clinic operation at UCSF will expand participation by California citizens in these novel clinical themes. The objective of this proposal from the Univ. of Calif., San Francisco is to […]

University of California, San Francisco (UCSF) CIRM Alpha Stem Cell Clinic

We propose a cellular trial operation at UCSF that will focus on childhood hereditary hematological and immunologic disorders and in anti-inflammatory lung cellular therapies. This alpha clinic operation at UCSF will expand participation by California citizens in these novel clinical themes. The objective of this proposal from the Univ. of Calif., San Francisco is to […]

Alpha Stem Cell Clinic for Northern and Central California

The UC Davis Alpha Clinic will provide pivotal resources to assist in the approval & conducting of stem cell/regenerative medicine clinical trials. A centralized space & personnel to administer the therapies to patients in the UCD 33-county catchment region (~6 million people in Northern/Central CA) Thanks to infrastructure & funding provided by CIRM, stem cell/regenerative […]

A Phase 1 Study of FT819 in Participants with Moderate to Severe Active Systemic Lupus Erythematosus

Therapeutic Candidate or Device iPSC-derived CD19 CAR T cell therapy Indication Systemic Lupus Erythematosus Therapeutic Mechanism Depletion of CD19+ B cells and plasmablasts Unmet Medical Need Potential for drug-free remission and reset of the immune system Project Objective Phase 1 trial completed Major Proposed Activities Site Activation and Patient Enrollment Clinical Trial Data Monitoring, Database […]

Phase 1 Study of Autologous E-SYNC T Cells in Adult Participants with EGFRvIII+ Glioblastoma

Therapeutic Candidate or Device Human T cells transduced with a lentiviral vector encoding anti-EGFRvIII synNotch-primed anti-EphA2/IL-13Rα2 chimeric antigen receptor. Indication Patients with MGMT unmethylated newly diagnosed GBM (Cohort 1), and patients for whom re-resection of recurrent GBM (Cohort 2). Therapeutic Mechanism In our proposed system, the first antigen EGFRvIII, which is expressed exclusively but heterogeneously […]

Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease

Therapeutic Candidate or Device Autologous stem cell-derived dopaminergic neuron replacement therapy. Indication Parkinson’s disease Therapeutic Mechanism The investigational cell therapy product is being studied as an autologous neuron replacement for Parkinson’s disease. Unmet Medical Need PD is a neurodegenerative disorder, affecting 1+ million people in the US. PD causes loss of dopamine (DA) neurons in […]

A PHASE 1B STUDY EVALUATING THE SAFETY AND EFFICACY OF AN ALLOGENEIC CELL THERAPY IN SUBJECTS WITH CLEAR CELL RENAL CELL CARCINOMA (ccRCC)

Therapeutic Candidate or Device An allogeneic anti-CD70 CAR-T cell product will be evaluated for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC). Indication Advanced or metastatic clear cell renal cell carcinoma (ccRCC) Therapeutic Mechanism The product is an allogeneic TRAC/CD52-knockout CAR T cell therapy targeting CD70. In this clinical study, the […]

A Phase I/IIa Study to Evaluate the Efficacy of Toca 511/Toca FC with Standard of Care Therapy in Newly Diagnosed High Grade Glioma

Therapeutic Candidate or Device DB107 (Toca 511), a retroviral replicating vector expressing yeast cytosine deaminase, which converts an antifungal prodrug to an anticancer drug Indication Newly diagnosed high-grade glioma Therapeutic Mechanism Retroviral replicating vector DB107 (Toca 511) spreads through tumors and delivers yeast cytosine deaminase (CD), which converts the antifungal prodrug 5-fluorocytosine (5-FC) to the […]