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 aged 18 or older who understand the study and are willing to sign a consent form agreeing to take part.
• People diagnosed with Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body — according to recognised international diagnostic guidelines, with active disease shown by standard scoring tools, and certain immune markers detected in blood tests, who have been on a stable standard treatment for at least 12 weeks before the study starts.
• People diagnosed with Inflammatory Muscle Disease (IIM) — a condition causing muscle inflammation — according to recognised international diagnostic guidelines, with at least one positive autoimmune blood marker, whose disease has not responded to standard treatments or has returned after a period of improvement.
• People diagnosed with Systemic Sclerosis (SSc, also known as scleroderma) — a disease causing hardening of the skin and organs — according to recognised international diagnostic guidelines, with at least one positive autoimmune blood marker, whose disease has not responded adequately to standard treatments for more than 6 months in total.
• People diagnosed with Rheumatoid Arthritis (RA) — a condition causing joint inflammation — according to recognised international diagnostic guidelines, with moderate or higher disease activity shown by a standard score, and whose disease has not responded to at least one standard RA medication after at least 3 months of treatment.
• People diagnosed with Immune Thrombocytopenia (ITP) — a condition where the immune system reduces platelet counts — according to recognised Chinese medical guidelines, whose condition has not responded to or has returned after at least one prior treatment, and whose platelet counts remain very low on at least two blood tests taken more than 24 hours apart.
• People diagnosed with Autoimmune Haemolytic Anaemia (AIHA) — a condition where the immune system destroys red blood cells — according to recognised Chinese medical guidelines, who did not respond well to first-line steroid treatment, and who are experiencing symptoms related to anaemia during the screening period.
• People whose blood test results meet minimum requirements for white blood cells, red blood cells, and platelets (the specific required levels vary depending on the condition — confirm exact values with the trial site).
• People whose liver function blood tests show results within acceptable ranges (confirm details with trial site).
• People with RA, ITP, or AIHA whose kidney function blood tests fall within acceptable ranges (confirm details with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is measured at 50% or higher.
• Women who could become pregnant and who agree to use effective contraception from the screening period until 6 months after the last dose, and agree not to donate eggs during this time; their male partners of reproductive potential must also agree to use effective contraception during this time.
• Men who could father children and who agree to use effective contraception from the screening period until 6 months after the last dose, with no plans for reproduction or sperm donation during this time; their female partners who could become pregnant must also agree to use effective contraception during this time.

Who may not be able to join:

• People with severe lupus kidney disease, or who have needed dialysis, or who received very high-dose steroid treatment for 14 or more days in the 8 weeks before screening.
• People who have had a brain or nervous system condition related to or separate from SLE in the 8 weeks before screening, such as seizures, stroke, or brain inflammation.
• People whose muscle disease falls into specific types not covered by this trial, including inclusion body myositis, juvenile myositis, or diabetic muscle wasting, or people with severe muscle or heart damage from non-immune causes.
• People with SSc who have high blood pressure in the lung arteries requiring treatment, rapidly worsening bowel disease requiring feeding through a vein, active stomach lining blood vessel abnormalities, or a history of kidney crisis caused by SSc.
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow or stem cell transplant at any point.
• People who have two or more immune-related conditions both requiring treatment throughout the body, if the trial doctor considers this makes them unsuitable (confirm with trial site).
• People with very low levels of a specific immune protein called IgA in their blood.
• People who have taken part in another clinical trial within 4 weeks before screening, or within 5 times the clearance period of that trial's drug, whichever is longer.
• People who have received a type of immune cell therapy called CAR-T therapy within 6 months before screening.
• People who have received B-cell depleting treatments (such as rituximab or similar drugs targeting CD19, CD20, or BAFF) within 1 month before screening, unless blood tests show that B-cell levels have returned to normal.
• People who have received certain non-standard SLE treatments within 3 months before screening, or within 5 times the clearance period of that drug, whichever is longer.
• People who have received a live or weakened vaccine within 4 weeks before screening, or who plan to receive one during the study.
• People who have an active infection at the time of the study.
• People who have had a severe allergic reaction (Grade 3 or 4) to a monoclonal antibody treatment in the past, or who are known to be allergic to any ingredient in the study drug (confirm details with trial site).
• People with a known history of illegal drug use, drug dependence, or alcohol dependence.
• People who have had major surgery within 4 weeks before screening, or minor surgery within 2 weeks before screening, unless wounds are fully healed.
• People who have had certain serious heart conditions within 6 months before screening, including severe heart failure, heart attack, unstable chest pain, uncontrolled heart rhythm problems, or other significant heart disease.
• People with other serious underlying health conditions — physical or mental — that the trial doctor considers would make participation unsafe or interfere with the study.
• People who have had most types of cancer diagnosed within the past 5 years (some early-stage or fully treated skin and localised cancers may still be eligible — confirm with trial site).
• Women who are pregnant or breastfeeding.
• People whose blood tests during screening show positive results for HIV, hepatitis B, hepatitis C, or syphilis.
• People found to have active or latent tuberculosis (TB) during screening.
• People who have had their spleen removed within 6 months before screening.
• People with ITP whose condition is caused by another disease (such as lupus, leukaemia, or antiphospholipid syndrome), or caused by a drug, or who have had a bleeding episode requiring treatment within 4 weeks before screening, or who have used certain blood-thinning or platelet-affecting medications regularly in the 2 weeks before screening, or who have a history of blood clots or clotting disorders or certain heart rhythm problems.
• People with ITP or AIHA whose blood clotting test results are considered clinically significant concerns by the trial doctor.
• People whom the trial doctor considers unsuitable for any other reason.

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