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New treatment option for Multiple Sclerosis
Official title An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
ClinicalTrials.gov ID: NCT07224373
What this study is testing
What is AZD0120 - Regimen 1?
AZD0120 - Regimen 1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply: Age
- Age ≥ 18-years-old to ≤ 60-years-old at the time of consent Type of Participant and Disease Characteristics
- Written informed consent in accordance with federal, local, and institutional guidelines
- Adequate physiological function and reserve at screening RMS Cohort Specific 4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban...
- Participants should have an EDSS of ≤ 6.5 at screening.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Any prior CAR-T or CAR-NK cell exposure.
- Underwent splenectomy within 12 months prior to signing the ICF.
- Received a solid organ transplant at any time or on an active transplant waiting list.
- Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
- Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply: Age
- Age ≥ 18-years-old to ≤ 60-years-old at the time of consent Type of Participant and Disease Characteristics
- Written informed consent in accordance with federal, local, and institutional guidelines
- Adequate physiological function and reserve at screening RMS Cohort Specific 4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin...
- Participants should have an EDSS of ≤ 6.5 at screening.
- Evidence of active disease (clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high how well it works disease-modifying therapy for ≥ 6 months. PMS Cohort Specific 7...
- Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.
- Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.
- Participants are excluded from the study if any of the following criteria apply:
- Any prior CAR-T or CAR-NK cell exposure.
- Underwent splenectomy within 12 months prior to signing the ICF.
- Received a solid organ transplant at any time or on an active transplant waiting list.
- Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
- Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:
- 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...
- Participant has significant psychiatric condition (active or history of).
- History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.
- Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening
- History of malignancy or ongoing treatment for prior malignancy.
- Inborn error of immunity and/or primary immunodeficiency.
- Seropositive for HIV or HTLV (including any history of HIV or HTLV).
- Active viral (any etiology, HBV, HCV) hepatitis are excluded.
- 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.
- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer.
- Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.
- Any contraindications to LP.
- Participants not willing, able, or are unsafe to take MRI scans as per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Liverpool, Australia
- Melbourne, Australia
- Waratah, Australia
- Montreal, Quebec, Canada
- Leipzig, Germany
- Magdeburg, Germany
- Würzburg, Germany
- Cambridge, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; St Louis, Missouri, United States; New York, New York, United States; Cleveland, Ohio, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.