AZD0120 for Refractory Systemic Lupus Erythematosus

This study is testing a new treatment called AZD0120 for adults with Systemic Lupus Erythematosus (SLE) that hasn't responded to other treatments. AZD0120 is a type of CAR T cell therapy, which uses your own immune cells to fight the disease. Before receiving AZD0120, you would have a short course of chemotherapy with Cyclophosphamide and Fludarabine. Researchers want to see if AZD0120 is safe, how well people tolerate it, and if it helps improve SLE symptoms. The study is open to adults aged 18 to 70 who meet certain health requirements. This study is currently unclear about its recruitment status and plans to enroll about 150 participants.

Study design
This is a Phase 1b/2, single-arm, open-label study, meaning all participants receive the same treatment and both you and the study team will know what treatment you are getting. It plans to enroll about 150 participants.
What's involved
You would receive a single infusion of AZD0120 after completing required lymphodepleting chemotherapy. You would need to follow a specific study visit schedule and other protocol requirements.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate safety, tolerability, and efficacy for up to 2 years after treatment.

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NCT06897930

A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

Recruiting
PHASE1Ages 18–70InterventionalTreatment
AstraZeneca
~150 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:AZD0120CyclophosphamideFludarabine

At a glance

Recruiting sites
9 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)
Measured over 2 years
+2 more outcomes measured
Lupus Erythematosus, Systemic
20 sites across 14 states
California2
Maryland2
New York2
North Carolina2
Washington2
Australia2
Florida1
Georgia1
AstraZeneca Clinical Study Information Center
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  • PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)2 years

    The incidence and severity of adverse events (AEs)

  • PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 22 years

    To determine the recommended phase 2 dose (RP2D) of AZD0120

  • PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE2 years

    Proportion of participants achieving SRI-4 response