E-SYNC T Cells / University of California - LARVOL DELTA

Operational strategies and regulatory navigation of an academic CAR T-cell trial for glioblastoma: Experience from the E-SYNC study (SNO 2025) - "The primary objective is to determine the safety of intravenously infused E-SYNC T-cells for the treatment of EGFRvIII+ GBM.All activities, including Investigational New Drug (IND)-enabling studies, Good Manufacturing Practice (GMP) cell manufacturing process development, quality assurance and quality control (QA/QC), and clinical coordination, were conducted in-house at UCSF without industry involvement...To support ongoing optimization and improve product integrity and patient safety, four IND amendments and protocol revisions have been implemented, including updates of the cryopreservation formulation and CAR induction assay method.Coordination among UCSF's GMP facility, QA/QC teams, research and clinical labs, and clinical investigators enabled consistent product release and timely bedside delivery. This experience offers a practical model for translating complex, next-generation cell and gene therapies from academic discovery to clinical implementation within a..."

CAR T-Cell Therapy • Brain Cancer • Gene Therapies • Glioblastoma • Solid Tumor

Operational strategies and regulatory navigation of an academic CAR T-cell trial for glioblastoma: Experience from the E-SYNC study (WFNOS 2025) - "The primary objective is to determine the safety of intravenously infused E-SYNC T-cells for the treatment of EGFRvIII+ GBM.All activities, including Investigational New Drug (IND)-enabling studies, Good Manufacturing Practice (GMP) cell manufacturing process development, quality assurance and quality control (QA/QC), and clinical coordination, were conducted in-house at UCSF without industry involvement...To support ongoing optimization and improve product integrity and patient safety, four IND amendments and protocol revisions have been implemented, including updates of the cryopreservation formulation and CAR induction assay method.Coordination among UCSF’s GMP facility, QA/QC teams, research and clinical labs, and clinical investigators enabled consistent product release and timely bedside delivery. This experience offers a practical model for translating complex, next-generation cell and gene therapies from academic discovery to clinical implementation within a..."

CAR T-Cell Therapy • Brain Cancer • Gene Therapies • Glioblastoma • Solid Tumor

Evaluation and Modeling of TransAct Addition for synNotch--CAR Induction Assay in E-SYNC T Cells (ASGCT 2025) - "The addition of TransAct improves the CAR induction assay based on more reasonable associations with dPCR-based VCN analyses. We have updated assay qualification to incorporate these changes and plan to use the modified assay for future E-SYNC T Cells product releases. Disease Focus of Abstract:Central Nervous System Disorders"

Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • EGFR • IL13RA2

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Hideho Okada, MD, PhD | Trial completion date: May 2030 ➔ Aug 2026 | Trial primary completion date: May 2030 ➔ Aug 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

UCSF Treats First Patient with Homegrown Chimeric Antigen Receptor (CAR) T-cell Therapy (UCSF) - "This month marked an important milestone for UCSF faculty and clinicians working to take on the challenge of glioblastoma multiforme (GBM). They successfully treated their first patient with a promising chimeric antigen receptor (CAR) T-cell therapy that was fully conceived, designed, optimized and manufactured here at UCSF....The primary goal of this phase 1 clinical study, led by Jennifer Clarke, MD, MPH, is to evaluate safety and toxicity of this therapy. However, the team will also be evaluating patient outcomes for early signs of efficacy. All the data collected from clinical trial will not only advance the E-SYNC development but also has to potential to inform development of future CAR T-cell therapies."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

UCSF Launches Clinical Trial on New CAR T Therapy for Glioblastoma (Inside Precision Medicine) - "Researchers at the University of California, San Francisco (UCSF) have begun enrollment for a clinical trial that uses a new, powerful version of CAR T as a potential therapy for glioblastoma, the most common and deadly adult brain cancer. The clinical trial is funded by an $11 million grant to UCSF by the California Institute for Regenerative Medicine (CIRM), which funds stem cell and gene therapy research...But the clinical trial will use a new, smarter version of CAR T developed in the UCSF lab of Wendell Lim, PhD, professor in the UCSF Department of Cellular and Molecular Pharmacology...The trial will be led by Jennifer Clarke, MD, professor of neurology at the UCSF Weill Institute for Neurosciences....A second trial, also to be conducted at UCSF, will commence next year and will be open to glioblastoma patients whether or not they have the mutation."

Enrollment open • Financing • New trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Hideho Okada, MD, PhD | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Hideho Okada, MD, PhD | Trial completion date: Aug 2029 ➔ May 2030 | Trial primary completion date: Aug 2025 ➔ May 2030

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Hideho Okada, MD, PhD

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor