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NCT07008378 | RECRUITING | Multiple Sclerosis

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

Genentech, Inc.

Brief 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).

Condition or disease

Multiple Sclerosis

Intervention/treatment

P-CD19CD20-ALLO1 Cells

Cyclophosphamide

Fludarabine

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-09-30
Estimated Primary Completion Date : 2032-08-31
Estimated Study Completion Date : 2032-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis

Location Details

NCT07008378

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Missouri

Washington University School of Medicine

St louis, Missouri, United States, 63110-1010