New cell therapy for MS enters human safety testing
NCT ID NCT07008378
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Multiple Sclerosis Comprehensive Care Center at Northwell Health
New York, New York, 10075, United States
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Rutgers University- Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1962, United States
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UCI Sue & Bill Gross Stem Cell Research Center
Irvine, California, 92697, United States
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UCSD Altman Clinical and Translational Research Institute
La Jolla, California, 92037-1337, United States
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Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
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Other studies related to the condition(s) this trial covers.
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