ZENITH
Research type
Research Study
Full title
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
IRAS ID
1013426
Contact name
Priya Vasudeva
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
This research tests AZD0120, a personalised cell therapy, for people with multiple sclerosis (MS) whose disease keeps relapsing or is progressing despite treatment. MS occurs when the immune system attacks the brain and spinal cord, causing problems with movement, vision, sensation, bladder and bowel function, thinking and fatigue. Current medicines do not work for everyone so there is a need to develop new treatments. AZD0120 is a type of treatment called Chimeric Antigen Receptor T-cell therapy and is made from a participant's own T cells (a type of immune cell). These cells are collected from the blood, modified in a laboratory to recognise and remove harmful B cells linked to MS, and then given back to the participant by infusion. AZD0120 targets two proteins on blood cells. The study will assess side effects and early signs of benefit. It will also help decide the best pre-treatment regimen with AZD0120 administration. This phase 1b, open-label study has three parts, including checking early safety, assessing pre-treatment options and confirming the best dose. About 18–24 adults aged 18–75 will join, with relapsing or progressive MS that has not improved on high‑efficacy therapies. Eligibility includes health checks and contraception requirements. People with active infections, certain heart/lung/neurological conditions, or recent live vaccines cannot take part. Active participation lasts around two years, and includes screening, white blood cell collection (apheresis), manufacturing of AZD0120 using participant’s white blood cells, short pre-treatment for some participants, AZD0120 infusion with at least 7 days in hospital, and regular follow‑up visits. There is no certainty that benefit will be received. It’s possible that participants’ condition may improve, stay the same, or get worse. Throughout the study, the team will closely monitor for side effects and health changes. Taking part is voluntary and participants may withdraw from the study at any time.
REC name
North East - York Research Ethics Committee
REC reference
26/NE/0003
Date of REC Opinion
18 Feb 2026
REC opinion
Further Information Favourable Opinion