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 fully understand what the trial involves and have signed a consent form agreeing to take part voluntarily.
• People aged 18 to 65 years (inclusive) at the time of signing the consent form, of any gender.
• People with Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body's own tissues — who were diagnosed using recognised 2019 medical classification guidelines, have certain positive blood markers (ANA, anti-dsDNA, or anti-Sm antibodies), whose disease has not responded well or has flared up despite receiving at least two immunosuppressant or biologic medications (each for at least 3 months), who have a disease activity score of at least 7 on a standard medical scale at screening, and who have been on a stable dose of existing treatments for a set minimum period before joining.
• People with Idiopathic Inflammatory Myopathy (IIM) — a group of conditions causing muscle inflammation — diagnosed using 2017 medical classification guidelines with a score meeting the required threshold, who have at least one positive relevant autoantibody, whose condition has not responded to or has relapsed after high-dose steroids plus at least one other immune-modifying medication (each for at least 3 months), who show active disease on several standard measures at screening, and who have been on stable medication doses for the required period.
• People with Systemic Sclerosis (SSc, also called scleroderma) — specifically the type that affects widespread areas of skin — diagnosed under 2013 medical guidelines, with a positive relevant autoantibody, whose condition was diagnosed within the past 5 years, has not responded to or relapsed after conventional treatment for more than 6 months, has a skin score between 15 and 30 on a standard scale with worsening in the past 6 months, and who have been on stable medication doses for the required period.
• Women who could become pregnant must use highly effective contraception from the screening period until 6 months after the last dose, not donate eggs, and ensure their male partner also uses effective contraception.
• Men who could father a child must use effective contraception from the screening period until 6 months after the last dose, not plan to donate sperm or attempt to conceive, and ensure their female partner also uses effective contraception.

Who may not be able to join:

• People who have had severe lupus-related kidney disease in the 8 weeks before screening, including very high protein in the urine, significantly reduced kidney function, a need for dialysis, or very high-dose steroid use for 2 or more weeks.
• People who have had a serious brain or nervous system condition (such as seizures, psychosis, stroke, or brain inflammation) in the 8 weeks before screening.
• People whose inflammatory muscle disease is a specific type such as inclusion body myositis or juvenile myositis, or who have severe muscle damage caused by something other than inflammatory myopathy (such as a stroke).
• People with SSc who have high blood pressure in the lungs requiring treatment, severe gut complications requiring feeding through a vein, a specific stomach blood vessel condition, or a history of SSc-related kidney crisis.
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant at any time.
• People who have another autoimmune disease that requires ongoing systemic (whole-body) treatment.
• People with a significant deficiency of a specific immune protein called IgA (blood level below 10 mg/dL).
• People with certain abnormal blood test results at screening, including liver enzyme levels more than twice the normal upper limit (except in some IIM patients), low red blood cell levels, low white blood cell counts, or low platelet counts.
• People who have taken part in another clinical trial within 4 weeks before screening, or within a set time period based on the previous trial drug (whichever is longer).
• People who received a type of cell therapy called CAR-T therapy within 6 months before screening.
• People who received certain B-cell-targeting treatments (such as rituximab) within 1 month before screening, unless blood cell levels have returned to normal.
• People who received certain non-standard SLE treatments within 3 months or a set drug-clearance period before screening (whichever is longer).
• People who received a live or weakened (attenuated) vaccine within 4 weeks before screening, or who plan to receive one during the trial.
• People who have had a serious active infection requiring antibiotic treatment within 14 days before screening.
• People who have had a severe allergic reaction (Grade 3–4) to another monoclonal antibody treatment, or who are known to be sensitive to any ingredient in the trial drug CC312 (confirm with trial site for borderline cases).
• People with a history of drug, substance, or alcohol abuse or addiction.
• People who have had major surgery within 4 weeks or minor surgery within 2 weeks before screening, where the wound has not fully healed.
• People who have had a significant heart event within 6 months before screening, such as a heart attack, unstable chest pain, severe heart failure, or uncontrolled heart rhythm problems.
• People with another serious underlying illness, psychiatric condition, or personal circumstances that the trial doctors consider would make participation unsafe or impractical.
• People diagnosed with cancer within the past 5 years.
• Women who are pregnant or breastfeeding.
• People who test positive at screening for HIV, hepatitis B, hepatitis C, or syphilis.
• People who have active or latent (inactive but present) tuberculosis, based on a standard blood test.
• People who the trial doctors consider ineligible for any other reason.

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