NCT07224373 · AstraZeneca
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
(ZENITH)
What this study is about
This trial is a Phase 1b, where both patients and doctors know the treatment given, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and how well patients handle the treatment in adult participants with Multiple Sclerosis.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Exclusion criteria
- 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 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.
- 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.
Where
- Tucson, Arizona
- Aurora, Colorado
- Washington D.C., District of Columbia
- St Louis, Missouri
- New York, New York
- Cleveland, Ohio
- Seattle, Washington
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations