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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		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
    P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
  • Drug: Cyclophosphamide
    Cyclophosphamide will be administered intravenously.
  • Drug: Fludarabine
    Fludarabine will be administered intravenously.

Recruiting Locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GN45773 https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.