Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

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).

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

Keywords

Multiple Sclerosis, Sclerosis, Cyclophosphamide, Fludarabine, P-CD19CD20-ALLO1 Cells

Eligibility

You can join if…

Open to people ages 18-60

  • 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 CAN'T join 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

Locations

  • UC Irvine, Sue & Bill Gross Stem Cell Research Center
    Irvine California 92697 United States
  • UC San Diego, Altman Clinical and Translational Research Institute
    La Jolla California 92037-1337 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT07008378
Phase
Phase 1 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated