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

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

  • Multiple Sclerosis

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