A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
Launched by GENENTECH, INC. · Jun 4, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called P-CD19CD20-ALLO1 for people with Multiple Sclerosis (MS), specifically those with progressive MS or relapsing MS. The main goals of the study are to check if this treatment is safe, how well it is tolerated by patients, and how it affects their cells and the disease itself. The trial is currently not open for participants yet, but once it starts, adults aged 18 to 60 with specific types of MS may be eligible to join.
To qualify for the trial, participants need to have a confirmed diagnosis of MS that meets certain criteria, such as showing signs of disability progression or having recent relapses while on treatment. They must also be free of relapses for 45 days before screening and have specific scores that measure their disability. Participants can expect to undergo various assessments, including MRI scans. It’s important to note that certain medical conditions and previous treatments may exclude individuals from participating, so discussing eligibility with a healthcare provider is essential.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 18-60 years (inclusive) at the time of signing Informed Consent Form
- * Diagnosis of progressive MS according to the revised McDonald 2017 criteria, and:
- • Expanded disability status scale (EDSS) score at screening, from 3 to 6 inclusive Evidence of disability progression and no relapses in the 2 years prior to screening
- • - Diagnosis of relapsing MS according to the revised McDonald 2017 criteria, and: Evidence of clinical relapses and MRI activity within two years prior to screening while on a disease modifying therapy
- • EDSS score at screening, from 0 to 6 inclusive
- • No relapses within 45 days of screening
- Exclusion Criteria:
- • Pregnant or breastfeeding, or intention of becoming pregnant within the timeframe in which contraception is required
- • Participants who have confirmed or suspected Progressive Multifocal Leukoencephalopathy (PML)
- • Known or suspected history of Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS) or neurotoxicity with prior therapies
- • Known presence of other neurologic disorders that may mimic MS
- • History of currently active primary or secondary (non-drug-related) immunodeficiency
- • Significant or uncontrolled medical disease which would preclude patient participation
- • High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV Ig, or acute blood product transfusions
- • History of recurrent serious infections or chronic infection
- • Prior treatment with CAR T-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point
- • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
- • Inability to complete an MRI scan
About Genentech, Inc.
Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
Rochester, New York, United States
Rochester, New York, United States
Tampa, Florida, United States
Portland, Oregon, United States
Cleveland, Ohio, United States
Irvine, California, United States
La Jolla, California, United States
Evanston, Illinois, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
New Brunswick, New Jersey, United States
Paramus, New Jersey, United States
Great Neck, New York, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Clinical Trials
Study Director
Genentech, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported