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RECRUITING
NCT06897930
PHASE1/PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-04-21

Completion Date

2029-05-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

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

Locations (16)

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

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