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

RECRUITINGPHASE1

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

A Phase I, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Patients With Multiple Sclerosis

NCT07008378•Genentech, Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

October 15, 2025

Primary Completion Date

August 31, 2032

Completion Date

August 31, 2032

Last Updated

January 16, 2026

Enrollment

ESTIMATED participants

Conditions

Multiple Sclerosis

Interventions

P-CD19CD20-ALLO1 Cells

BIOLOGICAL

Cyclophosphamide

DRUG

Fludarabine

DRUG

Contacts

Reference Study ID Number: GN45773 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

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Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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