Stanford Neuroimmunology Clinical Trials

Project BIG: The Stanford Brain Immune Gut Research Initiative
PI: Jeffrey Dunn, MD
Research Coordinators: Kristen Gee, and Taya Salman neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis (Kyverna/IIT)
NCT06138132
PI: Jeffrey Dunn, MD
Research Coordinator: Emma Martinez, neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants with Relapsed/Refractory Autoimmune Neurologic Diseases (KITE)
NCT07304154
PI: Kristin Galetta, MD
Research Coordinators: Jennifer Cuevas, and Kristen Gee, neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (BEAT-MS)
NCT04047628
PI: Jeffrey Dunn, MD
Research Coordinators: Taya Salman, and Emma Martinez, neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants with Refractory Progressive Forms of Multiple Sclerosis (BOBCAT/Autolus).
NCT07139743
PI: Jeffrey Dunn, MD
Research Coordinators: Bella Nguyen, and Emma Martinez neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Long-Term Follow-Up Study for Participants Previously Treated with KYV-101 (KYSA-4) (LTFU)
PI: Jeffrey Dunn, MD
Research Coordinator: Emma Martinez, neuroimmunologyresearch@stanford.edu
Status: Enrolling

R21 - Immune-mediated Cognitive Impairment in adult participants with NMOSD
PI: May Han, MD
Research Coordinators: Kristen Gee, and Jennifer Cuevas, neuroimmunologyresearch@stanford.edu
Status: Enrolling

Retinal Biomarkers of Inflammation and Degeneration in Multiple Sclerosis
PI: Heather Moss, MD
Research Coordinator: Kristen Gee, neuroimmunologyresearch@stanford.edu
Status: Enrolling

CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT04886492
PI: May Han, MD
Research Coordinator: Kristen Gee, neuroimmunologyresearch@stanford.edu
Status: Enrolling

A Phase 3 randomized, double-blind, efficacy and safety study comparing frexalimab (SAR441344) to placebo in adult participants with Nonrelapsing Secondary Progressive Multiple Sclerosis (FREVIVA)
NCT06141486
PI: Christopher Lock, MD
Research Coordinator: Jennifer Cuevas, neuroimmunologyresearch@stanford.edu
Status: Enrollment closed

A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study with an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanlixizumab in Adult Participants with Myelin Oligodentrocyte Glycoprotein (MOG) antibody-associated disease (MOG-AD) (cosMOG)
NCT05063162
PI: May Han, MD
Research Coordinator: Kristen Gee, neuroimmunologyresearch@stanford.edu
Status: Enrollment Closed

A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis (OLERO)
NCT05269004
PI: Jeffrey Dunn, MD
Research Coordinator: Jennifer Cuevas, neuroimmunologyresearch@stanford.edu
Status: Enrollment closed

A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis (BN42083/GAVOTTE)
NCT04548999
PI: Lucas Kipp, MD
Research Coordinator: Jennifer Cuevas, neuroimmunologyresearch@stanford.edu
Status: Enrollment closed