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Recruiting Phase 1 NCT07224373

An Open-label Study of AZD0120 in Adults With Multiple Sclerosis

Phase 1 – testing safety in a small group of people
Conditions: Multiple Sclerosis

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
This study will evaluate AZD0120 for safety, including DLTs and TEAEs, by the SRC for determination of the Recommended Phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.
Who can participate
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.
Interventions
AZD0120 - Regimen 1
BIOLOGICAL
AZD0120 - Regimen 2
BIOLOGICAL
Locations 19
Australia (4)
Research Site
Liverpool
NOT_YET_RECRUITING
Research Site
Melbourne
Research Site
Melbourne
NOT_YET_RECRUITING
Research Site
Waratah
NOT_YET_RECRUITING
Canada (1)
Research Site
Montreal , Quebec
NOT_YET_RECRUITING
Germany (3)
Research Site
Leipzig
NOT_YET_RECRUITING
Research Site
Magdeburg
NOT_YET_RECRUITING
Research Site
Würzburg
NOT_YET_RECRUITING
United Kingdom (2)
Research Site
Cambridge
NOT_YET_RECRUITING
Research Site
London
NOT_YET_RECRUITING
United States (9)
Research Site
Aurora , Colorado
NOT_YET_RECRUITING
Research Site
Cleveland , Ohio
NOT_YET_RECRUITING
Research Site
Milwaukee , Wisconsin
NOT_YET_RECRUITING
Research Site
New York , New York
NOT_YET_RECRUITING
Research Site
New York , New York
Research Site
Seattle , Washington
NOT_YET_RECRUITING
Research Site
St Louis , Missouri
Research Site
Tucson , Arizona
WITHDRAWN
Research Site
Washington D.C. , District of Columbia
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
09.12.2025
Completion date
07.12.2028
Registry ID
NCT07224373
Source
clinicaltrials.gov
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