Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends 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 San Diego, Altman Clinical and Translational Research Institute
    La Jolla California 92037-1337 United States
  • UC Irvine, Sue & Bill Gross Stem Cell Research Center
    Irvine California 92697 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