A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis

Running, not enrolling · Phase 1

Conditions studied: Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT07008378

Run by

Genentech, Inc.

People needed

60

Starts

2025-10-15

Expected to finish

2032-08-31

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCI Sue & Bill Gross Stem Cell Research Center — Irvine, California, United States
• UCSD Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rutgers University- Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Multiple Sclerosis Comprehensive Care Center at Northwell Health — New York, New York, United States

Full record on ClinicalTrials.gov

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