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 are 5 years old or older (any gender may apply)
- You have been diagnosed with lupus (SLE) using standard 2019 medical guidelines, and your disease is still moderate to severe despite at least 3 months of high-dose steroids, hydroxychloroquine, and at least 2 other standard lupus medications — or you cannot tolerate standard treatments
- Your lupus activity score (SLEDAI-2K) is 8 points or higher, meaning your disease is considered active
- Your heart is working well enough, with the heart's pumping function at 55% or above and no major problems on a heart tracing (ECG)
- Your kidneys are functioning at an adequate level (confirm with trial site for exact details)
- Your liver function blood tests are within an acceptable range
- Your blood oxygen level is 92% or above and you have no serious lung problems
- You are able to have a blood cell collection procedure (called leukapheresis) with no medical reasons preventing it
- If you are a woman who could become pregnant, you have a negative pregnancy test and agree to use effective contraception for the first year after receiving the treatment
- You (or your guardian, if applicable) are willing to sign a consent form confirming you understand and agree to take part in the study
Who may not be able to join:
- You have lupus affecting your brain or nervous system that has needed treatment within the last 60 days
- You have had serious kidney problems requiring dialysis or kidney replacement therapy in the last 3 months, or your doctor expects you may need intensive kidney treatment during the study
- You have a history of a heart condition you were born with, serious irregular heartbeats, significant fluid around the heart, serious heart muscle inflammation, or unstable vital signs requiring blood pressure medication
- You have an infection that cannot be controlled, or you have had an active infection needing full-body treatment within the last 3 months
- You have had an organ transplant or bone marrow/stem cell transplant within the last 3 months, or you have had a significant transplant rejection reaction (called GVHD, Grade 2 or above) within the last 2 weeks
- You have active or detectable hepatitis B, hepatitis C, HIV, or syphilis infections in your blood
- You experienced a serious immune flare-up called macrophage activation syndrome (MAS) within the last month (unless your doctor has confirmed it is safe for you to participate)
- You have previously received a type of cell therapy called CAR-T treatment (unless your doctor has confirmed it is safe for you to participate)
- You have active tuberculosis (TB) at the time of screening
- You received a live vaccine within the 4 weeks before screening
- You have a positive pregnancy blood test
- You have had or currently have any type of cancer
- You have taken part in another clinical trial within the last 3 months
- Your doctor believes there is any other reason you should not take part in this study
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
Principal Investigator: Jianhua Mao, MD, The Children's Hospital of Zhejiang University School of Medicine
Phone: 13516819071
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: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.