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New cell therapy for MS enters human safety testing

NCT ID NCT07008378

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This early-stage study tests an experimental cell therapy called P-CD19CD20-ALLO1 in 60 adults with multiple sclerosis. The main goal is to see if it is safe and how the body handles it. Researchers will also measure how long the cells last and how they affect the immune system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Multiple Sclerosis Comprehensive Care Center at Northwell Health

    New York, New York, 10075, United States

  • Rutgers University- Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901-1962, United States

  • UCI Sue & Bill Gross Stem Cell Research Center

    Irvine, California, 92697, United States

  • UCSD Altman Clinical and Translational Research Institute

    La Jolla, California, 92037-1337, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010, United States

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