RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AZD0120 in adults ages 18 to 60 with multiple sclerosis (MS). AZD0120 is a CAR T-cell treatment that uses modified immune cells. The study also checks how well people tolerate the treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 60 years old.
  • Sign a form agreeing to join after learning about the study.
  • Have enough body function and strength to take part safely.
  • For the relapsing group: have relapsing MS or active secondary progressive MS with relapses (flare-ups).
  • For the relapsing group: have an EDSS score of 6.5 or lower. EDSS measures disability from MS.
  • For the relapsing group: have flare-ups and MRI signs of active MS within the past 2 years despite at least 6 months on a highly effective MS drug, or be unable to tolerate the drug.
  • For the progressive group: have primary progressive MS or secondary progressive MS without flare-ups, and an EDSS disability score from 3.0 to 6.5.
  • For the progressive group: have a poor response to at least one highly effective MS drug taken for at least 6 months, or be unable to tolerate it.

Who can't join

  • Past CAR T-cell or CAR NK-cell treatment; spleen removal within 12 months before consent; any organ transplant or active transplant waiting list; or past treatment using your own blood-forming stem cells or radiation to lymph tissue.
  • A heart condition that makes the study too risky; another brain or nervous system disease that could affect safety checks; any seizure history, even if controlled; or a major mental health condition, now or in the past.
  • Another immune disease that needed ongoing medicines affecting the immune system; an immune system problem present from birth; any cancer history; or ongoing treatment for past cancer.
  • Serious bleeding or a condition causing bleeding within 90 days before screening.
  • Current or past HIV or HTLV infection, or active viral hepatitis (a liver infection).
  • Major surgery within 4 weeks before cell collection or treatment to reduce immune cells, or surgery planned during the study or within 4 weeks after study treatment.
  • Pregnant, breastfeeding, or planning pregnancy during the study or within 1 year after treatment, whichever is longer.
  • Unable or unwilling to safely have MRI scans or spinal taps, which collect fluid from around the brain and spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (9)

AZ

CO

DC

MO

NY

OH

WA

WI