Clinical Trials – Advancing Autoimmune Research

Monash Rheumatology, in collaboration with Monash Haematology, continues to lead Australia in pioneering clinical research for severe autoimmune diseases.

YTB323 Study – A Milestone in Autoimmune Therapy

We are proud to have successfully treated the first SLE patient in Australia with YTB323 (Novartis), a cutting-edge CAR-T cell therapy. Although this study is now closed to recruitment, it represents a major advancement in the treatment of autoimmune conditions.

• Monash Nephrology are currently recruiting Lupus Nephritis patients for the Phase II YTB study
• Unfortunately the Sana Allogeneic CAR-T Cell Therapy Study for SLE has now closed to recruitment.

Coming in March 2026: Allogeneic CAR-T Study

Launching in 2026, a second allogeneic CAR-T study will focus on:

• SLE
• Systemic Sclerosis (Scleroderma)
• Rheumatoid Arthritis
• Idiopathic Inflammatory Myositis

This study is conducted in close partnership with Monash Haematology, reinforcing our commitment to collaborative, multidisciplinary care and research excellence.

For referrals or more information, contact:

Professor Eric Morand – RheumatologyClinicalTrials@monashhealth.org

Phase III Sjögren’s Disease Study – Now Recruiting

Very exciting! We are now recruiting for a Phase III clinical trial investigating the efficacy and safety of Efgartigimod, a therapy designed to reduce disease-causing IgG antibodies.

Patients diagnosed with Sjögren’s Disease who meet eligibility criteria are encouraged to participate.

For referrals or more information, contact:
Professor Alberta Hoi – RheumatologyClinicalTrials@monashhealth.org

Still open-M23-699 Upadacitinib-mod-sev. active SLE

Only a few spots left, this study is 12mths 1:1 (Upa vs placebo) then up to 3 years of open label treatment!

Coming in March/April 2026-a Phase III study for

• DLE/SCLE (with or without SLE)-(CLASI>8)
• ACLE with SLE-(CLASI>8)

This study is for 6 months, an oral agent with option of open-label extension. Details to come.

Also coming in March 2026-exciting new T Cell Engager study

This open label, Phase I study is for severe refractory Rheumatoid Arthritis and SLE. Details to come.

Current Rheumatology clinical trials

Please click the link below to view all current clinical trials – updated quarterly with new trials.