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

NCT07008378 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: GN45773
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1

  Day 1 up to Day 29

• Number of Participants With Adverse Events (AEs)

  Up to 5 years

Secondary Outcomes (3)

• Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)

  Up to 5 years

• B-cell Levels in the Blood

  Up to 5 years

• Number of Participants With Anti-CAR T Antibodies

  Up to 5 years

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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.

Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

P-CD19CD20-ALLO1 Cells BIOLOGICAL

P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.

Dose Escalation

Cyclophosphamide DRUG

Cyclophosphamide will be administered intravenously.

Dose Escalation

Fludarabine DRUG

Fludarabine will be administered intravenously.

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Genentech, Inc.: lead
• Poseida Therapeutics, Inc., a member of the Roche Group: collaborator

Study Sites (5)

UCI Sue & Bill Gross Stem Cell Research Center

Irvine, California, 92697, United States

Location

UCSD Altman Clinical and Translational Research Institute

La Jolla, California, 92037-1337, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Rutgers University- Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901-1962, United States

Location

Multiple Sclerosis Comprehensive Care Center at Northwell Health

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): August 31, 2032
• Study Completion (Estimated): August 31, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)