NCT07224373RecruitingPhase 1
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
A Phase 1b, Open-label, Multi-center, Randomized Study Evaluating the Safety and Tolerability of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cells, in Adults With Refractory Relapsing or Progressive Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 21 Oct 2025
- Start date
- 9 Dec 2025
- Primary completion date
- 12 Dec 2028
- Lead sponsor
- AstraZeneca
- Diseases
- Multiple sclerosis
- NCT number
- NCT07224373
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 9 Dec 2025 to the primary completion date, 12 Dec 2028
- 17 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening
- 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.
Other illness
- 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 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.
- Participant has significant psychiatric condition (active or history of).
- History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.
- History of malignancy or ongoing treatment for prior malignancy.
- Seropositive for HIV or HTLV (including any history of HIV or HTLV).
- Active viral (any etiology, HBV, HCV) hepatitis are excluded.
Other
- Participants are excluded from the study if any of the following criteria apply:
- Inborn error of immunity and/or primary immunodeficiency.
- 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.
Criteria the registry did not label
- 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 Inclusion Criteria
- 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.
- 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 efficacy disease-modifying therapy for ≥ 6 months.
- PMS Cohort Specific Inclusion Criteria
- Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014.
- Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.
- Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.