Printed from Voxsanity (voxsanity.com.au) — NCT06943937 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Lupus Trial, Recruiting
NCT06943937
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:
- Adults between 18 and 65 years old (any gender) who meet the 2019 international classification criteria for Systemic Lupus Erythematosus (SLE)
- People in Cohort 1: Those with lupus that has affected the kidneys (lupus nephritis) that has not responded to treatment with steroids and at least 2 different immune-suppressing medications and/or biological therapies, with specific levels of protein in the urine and a kidney biopsy showing a particular pattern of damage (confirm with trial site for exact biopsy criteria)
- People in Cohort 2: Those with SLE-related low platelet counts (a blood clotting problem) that has not responded to high-dose steroid treatment plus at least one immune-suppressing medication, with platelet counts within a specific range on at least two consecutive blood tests, and where other causes of low platelets have been ruled out
- People whose bone marrow, liver, kidney, and heart function meet certain minimum levels as assessed by blood tests (confirm with trial site for exact values)
- People whose blood clotting results fall within acceptable limits
- People who are either unable to have children, or who are willing to use approved contraception (or abstain from sex) during treatment and for at least 12 months afterward
- Women who are not pregnant (confirmed by a blood test within 7 days before joining) and who are not breastfeeding
- People who are willing to participate voluntarily and sign a consent form
Who may not be able to join:
- People with severe drug allergies or serious hypersensitivity reactions
- People with an active infection (such as fungal, bacterial, or viral) that is not controlled or being treated
- People with certain central nervous system (brain and spinal cord) conditions — exceptions may apply for some specific conditions (confirm with trial site)
- People with heart failure that would prevent them from tolerating the treatment
- People born with an immune system condition that means they cannot produce normal levels of antibodies
- People who have had a cancer diagnosis within the past 5 years, with some possible exceptions for certain low-risk localised cancers (confirm with trial site)
- People with end-stage kidney failure
- People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis (specific test results apply — confirm with trial site)
- People who have had a serious blood clot in a vein or in the lungs within the 6 months before screening
- People with a severe mental illness or significant cognitive (thinking and memory) impairment
- People who have taken part in another clinical trial within the 3 months before screening
- People who have recently used immune-suppressing medications or biological therapies within specific timeframes before screening (confirm with trial site for exact timeframes)
- People who are pregnant, breastfeeding, or planning to become pregnant
- People whom the research team determines are not suitable for other reasons
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Phone: 010-63290612
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
Status
Recruiting
Phase
Phase 1
Sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
16 April 2025
Est. completion
25 April 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Incidence of Treatment-Emergent Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.