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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
At a glance
Conditions
Where it's being run
20 sites across 14 statesWho to contact
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What this trial measures
- 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