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:

General requirements (all participants):

• A person must be willing to sign a consent form agreeing to take part in the trial.
• A person must be between 18 and 60 years old (inclusive) at the time of signing the consent form, regardless of gender.
• A person must not have had a widespread active infection in the 2 weeks before the screening visit.
• A person who is capable of becoming pregnant must agree to use contraception during the trial.
• A person who is capable of becoming pregnant must have a negative pregnancy test before joining.

For people with Systemic Lupus Erythematosus (SLE) — a type of autoimmune disease:

• A person must have a confirmed SLE diagnosis meeting internationally recognised 2019 classification standards, with a disease history of at least 6 months.
• A person must have been receiving treatment with steroid medicines combined with immune-suppressing medicines and/or biological medicines for at least 3 months, at a stable dose for at least 2 weeks, and the disease must still be considered active.
• A person must have specific blood test results that show positive results for certain antibodies linked to lupus (antinuclear antibody, anti-double-stranded DNA antibody, or anti-Smith antibody).
• A person must have a disease activity score (called SLEDAI-2K) of 7 or higher at the screening stage, indicating significantly active disease.
• A person must have active involvement of organs beyond just the skin and mucous membranes (such as inside the mouth or nose).
• A person's kidneys must be functioning well enough, with the kidneys filtering at a calculated rate of at least 50 mL/min (confirm with trial site).
• A person's blood counts must meet minimum levels: white blood cells (specifically neutrophils) at or above a certain level, and haemoglobin (a measure of red blood cells) at or above 60 g/L, without having needed a blood transfusion or growth factor injections in the 7 days before screening.
• A person's liver function blood tests must be within acceptable ranges (no more than twice the upper limit of normal for liver enzymes and bilirubin).
• A person's blood clotting measures must be within acceptable ranges (confirm with trial site).
• A person's blood oxygen level must be 92% or above when breathing normal room air.
• A person's heart pumping function (measured by an ultrasound of the heart) must show a pumping efficiency of at least 40%, measured within 8 weeks before screening.

For people with Systemic Sclerosis (SSc) — also known as scleroderma:

• A person must meet the internationally recognised 2013 classification criteria for systemic sclerosis, specifically the diffuse type (a more widespread form of the condition).
• A person must also have lung scarring (interstitial lung disease) caused by SSc.
• A person must have a disease that has either not responded to standard treatment for more than 6 months, or has come back after a period of improvement (refractory disease), OR must show signs that the disease has been getting worse in the past 6 months — either through worsening skin involvement or a measurable decline in lung function (confirm specific thresholds with trial site).
• A person's kidneys must be functioning well enough, with a calculated filtering rate of at least 50 mL/min.
• A person's blood counts must meet minimum levels: neutrophils at or above a set level, and haemoglobin at or above 90 g/L, without a blood transfusion or growth factor injections in the 7 days before screening.
• A person's liver function blood tests must be within acceptable ranges.
• A person's blood clotting measures must be within acceptable ranges.
• A person's heart must show good stability and a pumping efficiency of at least 40% on heart ultrasound.

Who may not be able to join:

General exclusions (all participants):

• A person who has previously received CAR-T cell therapy or other genetically modified T-cell treatments, or who has had a major organ transplant.
• A person who has used B-cell targeting medicines (such as rituximab) within 2 months before screening.
• A person who has a known allergy or intolerance to the medicines used to prepare the body before the treatment, or to the trial treatment itself or its ingredients, or who has had a severe allergic reaction (such as anaphylactic shock) to similar treatments.
• A person who has been taking steroid medicine at a dose of 10 mg/day of prednisone or more (or an equivalent) in the 10 days before the treatment infusion.
• A person who has been using certain immune-suppressing medicines (including mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, or tacrolimus) within 10 days before the treatment infusion.
• A person who has used a type of medicine called a JAK inhibitor (such as tofacitinib, baricitinib, or ruxolitinib) within 3 days before the treatment infusion.
• A person who has received any vaccine (including live, inactivated, or RNA vaccines) within 1 month before screening.
• A person who has been diagnosed with cancer within the past 2 years, with some specific exceptions for certain treated and localised cancers (confirm details with trial site).
• A person who has had major surgery within 4 weeks before signing the consent form, or who is expected to need major surgery during the study, if the study doctor considers this poses an unacceptable risk.
• A person who tests positive for HIV, syphilis, active hepatitis B, or active hepatitis C at screening.
• A person who has a history of brain or nervous system conditions, including (but not limited to) stroke, epilepsy, seizures, severe brain injury, dementia, Parkinson's disease, or significant mental illness.
• A person who has had any of the following heart problems within the month before screening: severe heart failure (NYHA class III or IV), heart attack, unstable chest pain, uncontrolled or symptomatic irregular heart rhythms, or other serious heart conditions.
• A person who has taken part in another clinical trial within 3 months before screening, or who is still within a certain time window after their last dose in another trial.
• A person who currently has any uncontrolled active infection, including active tuberculosis.
• A person who has had thoughts of suicide in the 6 months before signing the consent form, or any suicidal behaviour in the previous 12 months, if the study doctor considers there to be significant risk.
• A person who is currently pregnant or breastfeeding.
• A person who the study doctor believes is unlikely to follow the study requirements, or who has other reasons that make participation unsuitable.

Additional exclusions for people with SLE:

• A person who has had severe lupus affecting the kidneys within 2 months before screening, requiring dialysis, or who needed very high-dose steroid treatment for 14 days or more.
• A person who has had a lupus crisis (a sudden severe worsening) within 1 month before screening, if the study doctor considers participation inappropriate.
• A person who has had brain or nervous system problems caused by lupus before screening (such as lupus-related headaches, seizures, or vision problems).
• A person who has had a significant bleeding event (grade 2 or higher) in the 30 days before screening (confirm with trial site).
• A person who has undergone plasma exchange or dialysis procedures within 14 days before screening.

Additional exclusions for people with SSc:

• A person whose lung function is severely reduced — specifically, lung capacity (FVC) at or below 30% of the expected value, or a measure of gas exchange (DLCO, corrected for haemoglobin levels) at or below 30% of the expected value.
• A person who has severe kidney disease or signs of a kidney crisis related to SSc.
• A person who is considered at risk of active tuberculosis at the time of screening.

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