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 diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) according to specific 2019 international classification guidelines, whose disease is still moderately to severely active despite at least 3 months of high-dose steroid treatment and at least 2 other standard medications, or who are unable to tolerate standard treatments
- People whose SLE disease activity scores 8 points or higher on a standard medical measurement scale called SLEDAI-2K
- People whose health allows for a procedure to collect white blood cells from the blood, with no medical reasons preventing this procedure
- Women of childbearing age whose pregnancy test result is negative, and who agree to use effective contraception for at least one year after receiving the trial treatment
- 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 within the last 30 days
- People with a history of certain serious heart conditions, including: a heart attack within the last 6 months, serious irregular heartbeats, severe heart failure (classified as NYHA Class IV), significant fluid around the heart, serious heart muscle inflammation, or unstable blood pressure requiring medication
- People whose kidneys, liver, or lungs are not functioning well enough — specifically if kidney filtration is very low or requires dialysis, if certain liver enzyme or bilirubin levels are significantly elevated, or if blood oxygen levels are below 92% without supplemental oxygen
- People with an active or uncontrolled infection that has required whole-body treatment within the past 3 months
- People who have had a bone marrow or stem cell transplant within the past 3 months, or who are experiencing a significant transplant-related immune reaction within the past 2 weeks
- People who have active Hepatitis B, Hepatitis C, HIV, or syphilis infections (confirm with trial site for specific test thresholds)
- People with active tuberculosis at the time of screening
- People who have received a live vaccine within the 4 weeks before screening
- People with a positive blood pregnancy test
- People with an active cancer diagnosis (some fully treated or resolved cancers may not apply — confirm with trial site)
- People who have taken part in another clinical trial within the past 3 months
- People whom the trial doctors consider unsuitable for any other medical 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: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.