Phase 1 Lupus Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) according to recognised medical guidelines (2019 ACR / 2023 EULAR criteria)
- Your lupus is currently moderately or highly active, based on standard scoring tools used by your doctor
- If you have lupus nephritis (lupus affecting the kidneys): a kidney biopsy has confirmed a specific type of active kidney involvement, you have a certain level of protein in your urine, and your kidneys are functioning at least at a minimum level (confirm with trial site)
- If you are in the general lupus group (not kidney-focused): you have not responded well enough to, or could not tolerate, at least one standard lupus treatment
- You have a positive blood test result for certain markers associated with lupus (such as ANA or related antibodies)
- Your blood counts and immune levels (such as white blood cells, B cells, and antibody levels) meet minimum required levels (confirm with trial site for exact values)
- If you are a woman who could become pregnant: you have a negative pregnancy test and agree to use contraception during the trial
- You are willing and able to give your informed consent to take part voluntarily
Who may not be able to join:
- You have received certain immune-targeting treatments (anti-CD19 or anti-CD20 therapies) in the last 6 months
- Your lupus is currently affecting your brain or nervous system (active CNS lupus)
- You have significant heart, lung, liver, or other serious uncontrolled health conditions
- You currently have an active infection or have had a serious infection recently
- You have active Hepatitis B, Hepatitis C, or HIV infection
- You have had major surgery within the last 4 weeks
- You have previously had an organ transplant or stem cell transplant
- You are currently pregnant or breastfeeding
- You have received certain blood treatments (IVIg or plasmapheresis) within the last 3 months
- You have received a live vaccine within the last 30 days
- Your doctor considers that any other condition makes you unsuitable for this trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 1-415-378-4738
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); Maximum tolerated dose (MTD); Number of participants experiencing dose-limiting toxicities (DLTs); Recommended Phase 2 Dose (RP2D)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.