A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractor… (NCT06897930) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
United States, Australia, Canada150 participantsStarted 2025-04-21
Plain-language summary
This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females aged 18 through 70 years inclusive at the time of consent.
. Written informed consent in accordance with federal, local, and institutional guidelines.
. Must be able and willing to adhere to the study visit schedule and other protocol requirements
. Adequate hepatic, renal, pulmonary, and cardiac function
. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
. Have used at least two standard immunosuppressants (including one biological agent).
. SLEDAI-2K score ≥6 at screening.
. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
Exclusion criteria
. Have received prior treatment with CAR T therapy directed at any target.
. Have received any therapy that is targeted to CD19 and/or BCMA
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is still in Phase 1b/Phase 2, meaning it's testing AZD0120 in people for the first time at this stage, what is currently known about its safety profile, and what are the risks I should be aware of before considering it?
2My lupus has already been called 'refractory,' meaning other treatments haven't worked well enough — how would you determine whether I've truly exhausted the standard-of-care options before discussing an experimental drug like AZD0120?
3One of the main goals of the Phase 1b portion is just to find the right dose — what does that mean for me practically, and how might the dose I receive differ from someone who joins later in the Phase 2 portion?
4What does 'refractory SLE' mean in the context of who this trial is looking for, and based on my specific history and disease activity, do you think I would even be a candidate worth discussing with the trial team?
5If I were to discuss enrolling in this trial, what would my treatment schedule look like day-to-day, and are there monitoring visits or restrictions that could affect my work, travel, or other care commitments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)
Timeframe: 2 years
2
PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2
Timeframe: 2 years
3
PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE