Phase 1 study for people with Lupus
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Investigational site | Brisbane | Australia | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* • Meet 2019 ACR / 2023 EULAR SLE classification criteria
* Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
* LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
* ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
* Positive ANA (≥1:80) or SLE associated autoantibodies
* Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
* Women of childbearing potential: negative pregnancy test; contraception required
* Voluntary informed consent
Exclusion Criteria:
* (Key) Inclusion Criteria:
* Meet 2019 ACR / 2023 EULAR SLE classification criteria
* Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
* LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
* ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
* Positive ANA (≥1:80) or SLE associated autoantibodies
* Required minimum lab values (lymphocytes ≥500/µL, B cells ≥25/µL, ANC ≥1000/mm³, IgG ≥600 mg/dL, etc.)
* Women of childbearing potential: negative pregnancy test; contraception required
* Voluntary informed consent
(Key) Exclusion Criteria:
* Anti CD19 or anti CD20 therapy within 6 months
* Active CNS lupus
* Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease
* Active infection or recent serious infection
* Positive HBV DNA or HCV RNA; HIV infection
* Major surgery within 4 weeks
* Prior organ or stem cell transplant
* Current pregnancy or breastfeeding
* Recent IVIg or plasmapheresis (\<3 months)
* Live vaccine within 30 days
* Any condition judged unsuitable by Investigator
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 March 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.