Phase 2 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 who are at least 18 years old.
• People who have given written, signed, and dated consent before any trial procedures begin.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body — meeting a specific set of internationally recognised diagnostic standards.
• People whose SLE remains highly active (measured using a disease activity scoring tool called BILAG) despite having already tried at least two standard treatments, such as certain immune-suppressing or biological medicines.
• People whose SLE affects at least one major organ, in one of these ways:
  • Active kidney inflammation (lupus nephritis), confirmed by kidney biopsy, with certain levels of protein in the urine and adequate kidney function, and no history of a kidney transplant.
  • Heart involvement from lupus (such as inflammation of the heart muscle or lining), confirmed by MRI or ultrasound.
  • Lung involvement from lupus (such as fluid around the lungs or raised pressure in the lung arteries), or lung disease where breathing test results are at or above 60% of expected levels.
• People who have a minimum level of a specific type of immune cell (CD3+ T cells) in their blood.
• Women who cannot become pregnant, or women who can become pregnant but have a negative pregnancy test at the start of the trial and before a specific treatment step, and who agree to use reliable contraception from the start of the trial until 12 months after receiving the trial treatment.
• People who have been fully vaccinated against COVID-19 according to the relevant public health recommendations, or who have had a confirmed COVID-19 infection within the past 6 months.

Who may not be able to join:

• People with serious, uncontrolled brain or nervous system problems, such as uncontrolled seizures, stroke, dementia, or paralysis.
• People with uncontrolled diabetes.
• People with lung disease caused by medication, or active tuberculosis.
• People whose breathing test results fall below 60% of expected levels across all measures tested.
• People whose SLE is currently causing significant neurological or psychiatric symptoms, as measured by the BILAG scoring tool.
• People who have had a cancer diagnosis, unless they have been cancer-free for at least 5 years (certain minor skin cancers may be exceptions — confirm with trial site).
• People with unstable heart disease, a reduced heart pumping function (below 50%), or active heart muscle inflammation (note: heart inflammation caused by lupus is a separate consideration — confirm with trial site).
• People with significantly reduced kidney function below a certain threshold.
• People with severe liver disease, as measured by a standard liver scoring system.
• People with a known history of HIV, or active hepatitis B infection.
• People with a history of hepatitis C infection, unless they have been treated and confirmed to have no detectable virus.
• People with any active, uncontrolled infection — including bacterial, viral, fungal, or COVID-19.
• People who have previously had a stem cell transplant or solid organ transplant.
• People who already have permanent, irreversible damage to major organs.
• People who have taken high-dose steroid tablets, certain immune-suppressing medicines, or live vaccines within specific time periods before a procedure called leukapheresis (a process to collect immune cells from the blood); or people who have previously received certain targeted immune therapies or gene therapies including CAR T cell therapy; or people currently taking cytotoxic (cell-killing) drugs.
• People with a known severe allergy to any medicine likely to be used during the trial, including those used in the preparatory treatment phase.
• People for whom the trial's procedures are considered medically unsuitable by the trial doctors.
• Women who can become pregnant and who do not agree to use highly effective contraception (or remain abstinent from heterosexual sex in a way consistent with their usual lifestyle, or have a partner who has had a confirmed successful vasectomy) for at least one month before the trial, throughout the trial, and for 12 months after the last dose of treatment. Women who may wish to have children after the trial should discuss the option of egg freezing before starting treatment, due to the risk of irreversible infertility. Egg donation must also be avoided throughout the trial and for 12 months after the last dose.
• Men with female partners who can become pregnant, who do not agree to use highly effective contraception (or remain abstinent, or are confirmed surgically sterile) throughout the trial and for 12 months after the last dose. Men should discuss sperm banking before starting treatment due to the risk of irreversible infertility, and must not donate sperm during this period.
• People who are already taking part in another clinical trial involving a treatment intervention.
• People who are unable to understand the procedures and risks involved in the trial.

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