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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine

• Registration Number: NCT07008378
• Lead Sponsor: Genentech, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-06
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-12
• Study Start: 2025-08-13
• Primary Completion: 2032-02-01
• Study Completion: 2032-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	P-CD19CD20-ALLO1 Cells	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Dose Escalation	Cyclophosphamide	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Dose Escalation	Fludarabine	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Dose Escalation	P-CD19CD20-ALLO1 Cells	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Dose Escalation	Cyclophosphamide	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Dose Escalation	Fludarabine	Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 5 years
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1	Day 1 up to Day 29

Secondary Outcome Measures

Name	Time	Method
B-cell Levels in the Blood	Up to 5 years
Number of Participants With Anti-CAR T Antibodies	Up to 5 years
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)	Up to 5 years

Trial Locations

Locations (13)

UC Irvine, Sue & Bill Gross Stem Cell Research Center; 🇺🇸 Irvine, California, United States

UC San Diego, Altman Clinical and Translational Research Institute; 🇺🇸 La Jolla, California, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Northwestern University, Northwestern Memorial Hospital; 🇺🇸 Evanston, Illinois, United States

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Washington University, John L. Trotter Multiple Sclerosis Clinic; 🇺🇸 Saint Louis, Missouri, United States

Rutgers University, Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Hackensack Meridian Neuroscience Institute, Paramus Campus; 🇺🇸 Paramus, New Jersey, United States

Northwell Health, Comprehensive MS Center; 🇺🇸 Great Neck, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Scroll for more (3 remaining)