RecruitingPhase 1Phase 2NCT06897930

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)

Sponsor

AstraZeneca

Enrollment

150 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Lupus Erythematosus, Systemic

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called AZD0120, a drug called Cyclophosphamide, and others for people with lupus erythematosus, systemic. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAZD0120

Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..

DRUGCyclophosphamide

Lymphodepletion - specified dose prior to receiving AZD0120

DRUGFludarabine

Lymphodepletion - specified dose prior to receiving AZD0120

Locations(18)

Research Site

San Francisco, California, United States

Research Site

Stanford, California, United States

Research Site

Tampa, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Chicago, Illinois, United States

Research Site

Bethesda, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

New York, New York, United States

Research Site

Syracuse, New York, United States

Research Site

Chapel Hill, North Carolina, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Richmond, Virginia, United States

Research Site

Seattle, Washington, United States

Research Site

Seattle, Washington, United States

Research Site

Darlinghurst, Australia

Research Site

Melbourne, Australia

Research Site

Toronto, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06897930

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