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:
- Adults aged 18 or older
- People who have been diagnosed with Systemic Lupus Erythematosus (SLE or lupus) according to specific 2019 international classification guidelines, whose disease remains moderate to severe despite at least 3 months of high-dose steroid treatment and at least 2 other standard lupus medications, or who cannot tolerate standard treatments
- People whose lupus disease activity score (SLEDAI-2K) is 8 points or higher, indicating moderate to severe active disease
- People whose health meets the requirements for a blood cell collection procedure called leukapheresis, with no medical reasons preventing it
- Women of childbearing age who have a negative pregnancy test and who agree to use effective contraception for at least one year after the treatment infusion
- People (or their legal guardians) who understand the purpose and process of the trial and agree in writing to take part
Who may not be able to join:
- People with lupus affecting the brain or nervous system that has required medical intervention in the past 30 days
- People with a history of certain heart conditions, including congenital heart disease, a heart attack within the past 6 months, serious abnormal heart rhythms, severely reduced heart function (NYHA Class IV), significant fluid around the heart, serious heart muscle inflammation, or unstable blood pressure requiring medication
- People whose kidney, liver, or lung function falls below certain levels — specifically, significantly reduced kidney filtering ability or need for dialysis; liver enzyme or bilirubin levels above set thresholds; or low blood oxygen levels without using supplemental oxygen (confirm specific thresholds with trial site)
- People with an uncontrolled or active infection that required whole-body treatment within the past 3 months
- People who received a stem cell transplant within the past 3 months, or who have had a significant transplant rejection reaction (Grade 2 or higher graft-versus-host disease) within the past 2 weeks
- People who test positive for active Hepatitis B virus, Hepatitis C virus, HIV, or syphilis at levels above normal reference ranges
- People with active tuberculosis at the time of screening
- People who received a live vaccine within the 4 weeks before screening
- People with a current positive blood pregnancy test
- People with an active cancer diagnosis (some fully treated, non-active cancers may be considered — confirm with trial site)
- People who have participated in another clinical trial within the past 3 months
- People whom the trial investigators determine are unsuitable for any other reason
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: 13705186409
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
Primary endpoints
The safety of CAR-T cell therapy in patients with refractory SLE [Safety]; The changes from baseline in SLEDAI-2K [efficacy]; The changes from baseline in PGA [efficacy]; The changes from baseline in BILAG-2004 [efficacy]; The number of patients with SRI-4 response [efficacy]; The number of patients with LLDAS [efficacy]; The number of patients with DORIS [efficacy]
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.