NCT06897930

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

A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Refractory Systemic Lupus Erythematosus (SLE)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts; First part is Phase 1b during which the study aims to assess safety and tolerability of AZD0120 in patients in refractory SLE cohorts Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
BIOLOGICAL	AZD0120	Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
DRUG	Cyclophosphamide	Lymphodepletion - specified dose prior to receiving AZD0120
DRUG	Fludarabine	Lymphodepletion - specified dose prior to receiving AZD0120

Timeline

• Start date: 2025-04-21
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2025-03-27
• Last updated: 2026-04-08

Locations

16 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study