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:

• You are 18 years old or older, of any gender
• You have been diagnosed with Systemic Lupus Erythematosus (SLE — a long-term immune system disease) using recognised medical guidelines, and your disease is currently active and has returned or not responded to previous treatments
• If you have lupus that affects your kidneys (lupus nephritis), it must be confirmed by a kidney biopsy and be currently active, with a specific type (III, IV, or V) identified
• You have been on steroids and at least two other treatments to manage your immune system for at least 3 months, but your symptoms are still poorly controlled or you cannot tolerate the treatments
• Certain specific lupus-related antibodies have been found in your blood (ANA, anti-dsDNA, or anti-Smith)
• You and your partner are willing to use reliable contraception for at least one year after receiving the treatment used in this trial
• You are able and willing to give written consent before the study begins

Who may not be able to join:

• Your lupus is affecting your nervous system at a severe level (confirm with trial site)
• You have previously had a solid organ transplant (such as a kidney, liver, or heart)
• You have previously had a stem cell transplant of any kind
• You have previously received a cell therapy treatment or a drug that targets a protein called BCMA
• You have a known history of a primary immune deficiency condition (a condition where your immune system does not work properly from birth or developed separately)
• You have another autoimmune disease at the same time that may affect how results are measured
• You have taken high-dose steroids (more than 20 mg per day of prednisone or equivalent) within 1 week before joining the trial
• You have taken immune-suppressing medications (other than steroids) within 1 week before joining
• You have received certain biological medicines or specific targeted drugs (such as rituximab, belimumab, or baricitinib) within 2 months before receiving the trial treatment
• You have had a blood-filtering procedure (plasmapheresis or double filtration) within 1 week before joining
• You have taken part in another clinical drug trial within 1 month before signing the consent form
• You have had major surgery recently or have major surgery planned within 4 weeks before joining or 12 weeks after receiving the treatment
• You have a history of substance misuse that has not been resolved, or a history of a psychiatric disorder
• You have an active infection that is not under control or that requires intravenous (drip) antibiotics or antiviral medicines
• You have active hepatitis B, hepatitis C, HIV, cytomegalovirus (CMV), or syphilis infections detected through specific blood tests (confirm with trial site for exact test thresholds)
• Your blood test results show that your white blood cells, a specific type of immune cell (lymphocytes), or your red blood cells (haemoglobin) are too low
• You have serious heart problems, such as a recent heart attack, severe heart failure, serious abnormal heart rhythms, or poor heart pumping function
• You have severe asthma or severe chronic lung disease (COPD), or your blood oxygen level at rest is too low
• You have a significant risk of serious bleeding, as assessed by the study doctor
• You have severe liver failure, as assessed by the study doctor
• You have a history of severe kidney disease, or your kidneys are currently functioning at a low level based on a specific calculation
• You have had a stroke or a mini-stroke (TIA) within the past 6 months
• You have any other serious uncontrolled health condition that the study doctor believes may interfere with the trial
• You have been diagnosed with cancer in the past 5 years (some exceptions apply for certain fully treated cancers — confirm with trial site)
• You have a known severe allergy to any ingredient in the trial treatment (eque-cel)
• You are pregnant or breastfeeding
• The study doctor considers you unsuitable for the trial for any other reason

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