RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-09-30

Study Completion:2032-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07008378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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: * EDSS score at screening, from 0 to 6 inclusive * No relapses within 45 days of screening	* 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

Inclusion Criteria

Exclusion 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:
* EDSS score at screening, from 0 to 6 inclusive
* No relapses within 45 days of screening

* 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

Contacts and Locations

Study Contact

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

CONTACT

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Genentech, Inc.

Study Locations (Sites)

Washington University School of Medicine

St Louis, Missouri, 63110-1010

United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-30

Study Completion Date2032-08-31

Study Record Updates

Study Start Date2025-09-30

Study Completion Date2032-08-31

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis