Could a cancer therapy tame multiple sclerosis? new trial launches
NCT ID NCT07224373
First seen Jun 26, 2026 · Last updated Aug 26, 2026 · Updated 5 times
Summary
This early-stage trial is testing a new treatment called AZD0120 for people with multiple sclerosis (MS) that has not responded to other therapies. AZD0120 is a type of immune cell therapy (CAR-T) designed to target and reset the immune system. The study will enroll 24 adults aged 18-60 and focus primarily on safety and tolerability over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD0120, a type of immune cell therapy (CAR-T cells) that targets two proteins (CD19 and BCMA) on immune cells
- What this could lead to
- If this treatment is safe and effective, it could offer a new way to control multiple sclerosis by resetting the immune system, potentially reducing relapses and progression.
- What could go wrong
- This is a very early (Phase 1b) and small trial with only 24 people, so safety and effectiveness are not yet proven. CAR-T therapy can cause serious side effects like cytokine release syndrome or infections.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
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.
Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Age ≥ 18-years-old to ≤ 60-years-old at the time of consent Type of Participant and Disease Characteristics 2. Written informed consent in accordance with federal, local, and institutional guidelines 3. Adequate physiological function and reserve at screening RMS Cohort Specific Inclusion Criteria 4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin et al 2014. 5. Participants should have an EDSS of ≤ 6.5 at screening. 6. Evidence of active disease (clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high efficacy disease-modifying therapy for ≥ 6 months. PMS Cohort Specific Inclusion Criteria 7. Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014. 8. Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening. 9. Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Any prior CAR-T or CAR-NK cell exposure. 2. Underwent splenectomy within 12 months prior to signing the ICF. 3. Received a solid organ transplant at any time or on an active transplant waiting list. 4. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation. 5. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion: 6. Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics. 7. Participant has significant psychiatric condition (active or history of). 8. History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents. 9. Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening 10. History of malignancy or ongoing treatment for prior malignancy. 11. Inborn error of immunity and/or primary immunodeficiency. 12. Seropositive for HIV or HTLV (including any history of HIV or HTLV). 13. Active viral (any etiology, HBV, HCV) hepatitis are excluded. 14. Major surgery within 4 weeks prior to apheresis or lymphodepletion or has surgery planned during the study or within 4 weeks after study treatment administration. 15. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer. 16. Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator. 17. Any contraindications to LP. 18. Participants not willing, able, or are unsafe to take MRI scans as per protocol.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
WITHDRAWNTucson, Arizona, 85719, United States
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Research Site
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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Research Site
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Research Site
RECRUITINGSt Louis, Missouri, 63110, United States
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Research Site
RECRUITINGNew York, New York, 10016, United States
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Research Site
RECRUITINGNew York, New York, 10032, United States
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Research Site
NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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Research Site
RECRUITINGSeattle, Washington, 98122, United States
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Research Site
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Research Site
NOT_YET_RECRUITINGLiverpool, 2170, Australia
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Research Site
RECRUITINGMelbourne, 3000, Australia
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Research Site
NOT_YET_RECRUITINGMelbourne, 3004, Australia
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Research Site
NOT_YET_RECRUITINGWaratah, 2298, Australia
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Research Site
NOT_YET_RECRUITINGMontreal, Quebec, H3A 1A1, Canada
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Research Site
WITHDRAWNLeipzig, 04103, Germany
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Research Site
WITHDRAWNMagdeburg, 39120, Germany
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Research Site
WITHDRAWNWürzburg, DE-97072, Germany
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Research Site
WITHDRAWNCambridge, CB2 2QQ, United Kingdom
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Research Site
WITHDRAWNLondon, SE5 9RS, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Simulator-Based assessment of driving performance in patients with Parkinson's disease and multiple sclerosis
- Contrasting chronic inflammation and neurodegeneration using the human amniotic mesenchymal cell secretome as an innovative therapeutic strategy
- VIGIP-SEP2: evaluation of the impact of the training of patients by nurses on the adverse drug reaction reporting by RRMS patient via a mobile application: a randomized real-life study
- Five-second sprints on a bike: a new test for multiple sclerosis symptoms
- A new way to gauge balance training intensity in MS?
- A PET tracer aims to reveal the brain inflammation MRI misses in MS