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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAstraZeneca

About this trial

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 criteria

Qualifiers

Males or females aged 18 through 70 years inclusive at the time of consent.

Written informed consent in accordance with federal, local, and institutional guidelines.

Must be able and willing to adhere to the study visit schedule and other protocol requirements

Adequate hepatic, renal, pulmonary, and cardiac function

Disqualifiers

None

Trial design

Treatments tested in this trial

  • AZD0120
  • Cyclophosphamide
  • Fludarabine

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

18
Australia
Research Site2010, Darlinghurst Australia
Research Site3000, Melbourne Australia
Canada
Research SiteM5T 2S8, Toronto Canada
United States
California
Research Site94143, San Francisco United States

Sponsors and collaborators

AstraZeneca

Lead sponsor