Early Phase 1 Lupus Trial, Recruiting

Written by an AI model from the 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 have read and understood the study information and have signed a consent form agreeing to follow all study procedures
• People aged 18 to 65 years old (inclusive) at the time of signing the consent form, of any gender
• People who have had no widespread active infection (such as infectious pneumonia or tuberculosis) in the 2 weeks before the screening visit
• Women who are physically capable of becoming pregnant must agree to use highly effective birth control from at least 28 days before the start of the pre-treatment preparation phase until 1 year after receiving the study treatment, and must not donate eggs during that period; their male partners who are capable of fathering children must also agree to use effective barrier contraception from the start of the preparation phase until 1 year after the study treatment, and must not donate semen or sperm during the study
• Women who are physically capable of becoming pregnant must have a negative blood pregnancy test at screening and within 48 hours before chemotherapy begins
• People who meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE) — a recognised medical standard for diagnosing lupus — and have had the condition for at least 6 months
• People who have been treated with corticosteroids (such as prednisone) combined with immunosuppressant medications and/or biologics for at least 3 months before screening, at a stable dose for at least 2 weeks, and whose disease is still considered active; specific steroid dose requirements apply depending on whether steroids are used alone or in combination (confirm with trial site)
• People who test positive for at least one of the following lupus-related antibodies during screening: antinuclear antibody, anti-double-stranded DNA antibody, or anti-Smith antibody
• People with a lupus disease activity score (SLEDAI-2K) of 7 or higher during screening, or those with significant organ complications such as severe immune-related low platelet counts or a confirmed active form of lupus kidney disease (type III or IV, with or without type V)
• People whose lupus is actively affecting internal organs such as the kidneys, heart, lungs, joints and muscles, blood, or blood vessels during screening (skin or mucous membrane involvement alone does not meet this criterion)
• People whose organ function meets all of the following minimum levels at screening:
  • Kidneys: adequate kidney filtering function (creatinine clearance of at least 50 mL/min, calculated without extra fluid support)
  • Bone marrow/blood counts: sufficient levels of white blood cells and red blood cells, without having received blood transfusions or growth factor injections in the 7 days before testing
  • Liver: liver enzyme and bilirubin levels within twice the normal upper limit
  • Blood clotting: clotting measurements within 1.5 times the normal upper limit
  • Lungs: blood oxygen level of at least 92% when breathing normal indoor air
  • Heart: heart pumping function of at least 50%, confirmed by a heart ultrasound within the 8 weeks before screening

Who may not be able to join:

• People who have had severe lupus kidney disease in the past 2 months requiring dialysis, or who have taken high-dose steroids (prednisone 100 mg/day or equivalent) for 14 days or more
• People who have had plasma exchange, plasmapheresis, or dialysis in the past 30 days, or who have experienced a lupus crisis in the past 30 days
• People who have had a significant bleeding episode (Grade 2 or higher) in the past 30 days, or who require ongoing anticoagulant (blood-thinning) medication
• People who have had any of the following heart conditions in the 30 days before screening: severe heart failure, heart attack, unstable chest pain, uncontrolled or symptomatic irregular heart rhythms, or other clinically significant heart disease
• People who have had lupus-related symptoms affecting the brain or nervous system before screening, including lupus headache, seizures, memory or cognitive problems, reduced intellectual function, or vision problems
• People with a history of any of the following neurological or brain conditions before screening: stroke, brain inflammation, epilepsy, convulsions or seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, inflammation of brain blood vessels, cognitive dysfunction, organic brain syndrome, or psychosis
• People who have had a systemic active infection in the 2 weeks before screening, including active tuberculosis
• People who have previously received CAR-T cell therapy or other gene-modified T cell treatments, or who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant
• People who are allergic or intolerant to diuretics, tocilizumab, or who have had life-threatening allergic reactions or intolerances to the study treatment (CT1195E) or its ingredients, including a substance called DMSO, or who have a history of severe allergic reactions such as anaphylactic shock
• People who have used B-cell targeted medications such as rituximab in the 3 months before screening
• People who have used other biologics such as TACI-Ig or belimumab (Benlysta) in the 12 weeks before screening
• People who have used prednisone (or equivalent) at 10 mg/day or higher in the 2 weeks before the study treatment infusion (confirm with trial site, as some steroid types may be permitted)
• People who have used certain immunosuppressant medications that affect T cells — including mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, or tacrolimus — in the 2 weeks before the study treatment infusion
• People who have used JAK inhibitor medications (such as tofacitinib, baricitinib, or ruxolitinib) in the 2 weeks before the study treatment infusion
• People who have received any type of vaccine (live-attenuated, inactivated, or RNA-based) in the month before screening
• People who have been diagnosed with a malignant (cancerous) tumour in the 2 years before signing the consent form, with some exceptions for certain treated and resolved cancers (confirm with trial site)
• People who have had major surgery in the 4 weeks before signing the consent form, or who plan to have major surgery during the study, if the investigator considers this to pose an unacceptable risk
• People who test positive during screening for HIV, syphilis, active hepatitis B, or active hepatitis C
• People who have participated in another clinical trial in the past 3 months, or who are still within 5 half-lives of the last dose from a previous trial
• People with other major long-term health conditions that are not well controlled and that the investigator considers may increase risk
• People who have had suicidal thoughts in the past 6 months or any suicidal behaviour in the past 12 months, if researchers consider there to be a significant risk
• Women who are pregnant or breastfeeding
• People who the investigator believes are unlikely to follow the study procedures, are unwilling or unable to meet the study requirements, or have any other reason that makes participation unsuitable

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