Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07008378

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCI Sue & Bill Gross Stem Cell Research Center, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P-CD19CD20-ALLO1 Cells

Biological

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

Cyclophosphamide

Drug

Cyclophosphamide will be administered intravenously.

Fludarabine

Drug

Fludarabine will be administered intravenously.

Primary outcomes

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

    Time frame: Day 1 up to Day 29

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 5 years

Secondary outcomes

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

    Time frame: Up to 5 years

  2. B-cell Levels in the Blood

    Time frame: Up to 5 years

  3. Number of Participants With Anti-CAR T Antibodies

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Poseida Therapeutics, Inc., a member of the Roche Group

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jun 6, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.