A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0120: Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
Cyclophosphamide: Lymphodepletion - specified dose prior to receiving AZD0120
Fludarabine: Lymphodepletion - specified dose prior to receiving AZD0120
Study 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.
Eligibility
Primary outcome measure(s)
- 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 2 — 2 years
To determine the recommended phase 2 dose (RP2D) of AZD0120 - PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE — 2 years
Proportion of participants achieving SRI-4 response
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | San Francisco | California | Recruiting |
| Research Site | Stanford | California | Not Yet Recruiting |
| Research Site | Tampa | Florida | Suspended |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Bethesda | Maryland | Withdrawn |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | Syracuse | New York | Recruiting |
| Research Site | Chapel Hill | North Carolina | Recruiting |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Richmond | Virginia | Not Yet Recruiting |
| Research Site | Seattle | Washington | Recruiting |
| Research Site | Seattle | Washington | Recruiting |
| Research Site | Darlinghurst | Australia | Recruiting |
| Research Site | Melbourne | Australia | Not Yet Recruiting |
| Research Site | Toronto | Canada | Not Yet Recruiting |
| Research Site | Bristol | United Kingdom | Not Yet Recruiting |
More AstraZeneca trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06897930 on ClinicalTrials.gov ↗ ← All trials in the UK