Phase 1 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 5 years or older, of any gender.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) according to specific 2019 international classification standards.
• People whose SLE remains moderately to severely active despite at least 3 months of treatment with high-dose steroids, a medication called hydroxychloroquine, and at least 2 other immune-suppressing or biologic medications — or people who are unable to tolerate standard SLE treatments.
• People with a disease activity score (called SLEDAI-2K) of 8 points or higher, indicating moderate to severe lupus activity (confirm with trial site).
• People whose heart function meets a specific minimum level (left ventricular ejection fraction of at least 50%) with no significant abnormalities on a heart tracing test (ECG).
• People whose kidneys are functioning above a certain minimum level (eGFR of at least 30 mL/min/1.73m²) (confirm with trial site).
• People whose liver function test results are within an acceptable range as defined by the trial.
• People who do not have severe lung disease and whose blood oxygen levels are at least 92% without needing supplemental oxygen.
• People who are medically suitable for a blood cell collection procedure called leukapheresis.
• Women of childbearing age who have a negative pregnancy test and who agree to use effective contraception until at least one year after receiving the treatment.
• People (or their legal guardians, for younger participants) who agree to take part in the trial and sign a consent form confirming they understand what the trial involves.

Who may not be able to join:

• People who have had lupus-related brain or nervous system symptoms requiring medical intervention in the 60 days before joining, such as seizures, confusion, or stroke-like events.
• People with certain serious heart conditions, including significant irregular heartbeats, certain types of rapid heart rhythms, significant fluid around the heart, severe heart muscle inflammation, or unstable vital signs requiring medication to maintain blood pressure.
• People who have an active infection requiring treatment throughout the body, or who have had an uncontrolled infection in the 3 months before joining.
• People who have received an organ transplant or a stem cell transplant in the 3 months before joining, or who have had a significant transplant rejection reaction (called graft-versus-host disease, grade 2 or above) in the 2 weeks before joining.
• People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis under conditions specified by the trial.
• People who have had a serious immune complication called macrophage activation syndrome in the month before joining (unless the treating doctor has determined there is no ongoing safety risk).
• People who have previously received a type of cell therapy called CAR-T therapy (unless the treating doctor has determined there is no ongoing safety risk).
• People who have active tuberculosis at the time of joining.
• People who have received any vaccination in the 4 weeks before joining.
• People with a positive blood pregnancy test.
• People who have been diagnosed with cancer or a malignant tumour before joining.
• People who have participated in another clinical trial in the 3 months before joining.
• People whom the trial doctors consider unsuitable for any other reason.

Important: Always verify eligibility with the trial site directly before applying.