Clinical Trial

Disease: Multiple Sclerosis, (NCT07008378)

Disease info:

Multiple sclerosis (MS) is a chronic autoimmune disease whereby the immune system attacks the myelin sheath, which is the protective covering of the nerve fibres in the brain and spinal cord. MS causes myelin sheath breakdown, interrupting communication between the brain and body and eventually leading to permanent nerve damage. MS can be mild or severe and affects the nervous system, potentially impacting mobility, vision, and cognitive function. Individuals with MS often experience periods of symptom flares (relapses) and remission, though the disease course varies greatly.

While the exact cause of MS is unknown, genetic and environmental factors may increase risk. Risk factors include being female, age 20-40 at onset, family history, certain infections such as Epstein-Barr virus, being of Northern European descent, living in a temperate climate, having low vitamin D levels, obesity, and smoking.

Common symptoms include numbness or tingling, weakness, coordination problems, fatigue, electric-shock sensations with neck movement, vision loss often with eye pain, trouble walking, dizziness, bladder and bowel dysfunction, slurred speech, and cognitive problems affecting memory and thinking. Other symptoms include mood changes and muscle stiffness.

There is currently no cure for multiple sclerosis. Treatment involves managing relapses, modifying disease progression, and controlling symptoms.

Source: Mayo Clinic.

Frequency:
An estimated 2.9 million people in the world have multiple sclerosis (Source: MS Trust UK)
Official title:
An estimated 2.9 million people in the world have multiple sclerosis.
Who:

Name: Reference Study ID Number: GN45773 forpatients.roche.com

Phone Number: 888-662-6728 (U.S.)

Email: global-roche-genentech-trials@gene.com

Sponsor:

Genentech, Inc.

Partners:

Poseida Therapeutics, Inc., a member of the Roche Group

Locations:

United States, California Irvine, California, United States, 92697 UC Irvine, Sue & Bill Gross Stem Cell Research Center

La Jolla, California, United States, 92037-1337 UC San Diego, Altman Clinical and Translational Research Institute

United States, Florida Tampa, Florida, United States, 33620 University of South Florida

United States, Illinois Evanston, Illinois, United States, 60208 Northwestern University, Northwestern Memorial Hospital

United States, Maryland Baltimore, Maryland, United States, 21201-1642 University of Maryland, Baltimore

United States, Missouri Saint Louis, Missouri, United States, 63110-1010 Washington University, John L. Trotter Multiple Sclerosis Clinic

United States, New Jersey New Brunswick, New Jersey, United States, 08901-1962 Rutgers University, Robert Wood Johnson Medical School

Paramus, New Jersey, United States, 07652 Hackensack Meridian Neuroscience Institute, Paramus Campus

United States, New York Great Neck, New York, United States, 11021 Northwell Health, Comprehensive MS Center

Rochester, New York, United States, 14642-0001 University of Rochester Medical Center

United States, Ohio Cleveland, Ohio, United States, 44195-0001 Cleveland Clinic

United States, Oregon Portland, Oregon, United States, 97239-3011 Oregon Health and Science University

United States, Pennsylvania Pittsburgh, Pennsylvania, United States, 15213 University of Pittsburgh Medical Center, Magee Women's Hospital

United States, Virginia Charlottesville, Virginia, United States, 22908 University of Virginia

Study start:
Aug. 1, 2025
Enrollment:
60
Gene editing method:
Cas-CLOVER
Type of edit:
Gene knockout and insertion
Gene:
TRAC, MHC1, Anti-CD19 CAR
Delivery method:
PiggyBac transposon - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple sclerosis (PMS) and relapsing multiple sclerosis (RMS).

Last updated: Jun. 15, 2025
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