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 the trial's purpose and potential risks, are willing to take part, and have signed the informed consent form.
• People aged 18 to 65 years (inclusive), of any gender.
• People who have been diagnosed with systemic lupus erythematosus (SLE) using the 2019 international classification guidelines.
• People whose SLE is still active despite standard treatment, as shown by specific disease activity scores (SLEDAI-2000 score of 7 or higher, with at least one high-severity or two moderate-severity areas affected).
• People who test positive for at least one of the following blood markers at screening: ANA at a level of 1:80 or higher, anti-dsDNA antibody, or anti-Sm antibody.
• People who have not responded well enough to at least two standard SLE treatments before screening — including at least one immunosuppressant and/or biologic — and who have been on a stable dose of their current medications for at least 12 weeks before the first dose (with no dose changes in the last 30 days).
• Women who could become pregnant must agree to use highly effective contraception from screening until 6 months after the last dose, and must not donate or have eggs collected during this time; their male partners who could father a child must also use effective contraception.
• Men who could father a child must agree to use highly effective contraception from screening until 6 months after the last dose, with no plans for fertility procedures or sperm donation; their female partners who could become pregnant must also use effective contraception during this time.

Who may not be able to join:

• People who had severe lupus-related kidney disease in the 8 weeks before screening, defined by very high levels of protein in the urine, high creatinine levels, needing dialysis, or requiring very high-dose steroids or other restricted medications.
• People who had a serious nervous system condition (such as seizures, psychosis, stroke, brain inflammation, or blood vessel inflammation in the brain) in the 8 weeks before screening, whether or not it was caused by SLE.
• People who have had a major organ transplant (heart, lung, kidney, or liver) or a stem cell or bone marrow transplant at any time.
• People who have another autoimmune disease that requires whole-body (systemic) treatment, except for Sjögren's syndrome.
• People with very low levels of a specific immune protein called IgA (below 10 mg/dL).
• People with certain abnormal blood test results at screening, including: liver enzymes or bilirubin more than twice the normal limit; low red blood cell levels (haemoglobin below 85 g/L); low white blood cell count; low neutrophil count; low platelet count; or significantly reduced kidney filtering function (eGFR below 30 mL/min/1.73 m²).
• People who have taken part in another clinical trial — including cell or gene therapy trials — within 4 weeks before screening, or within 5 half-lives of the trial drug used, whichever is longer.
• People who received CAR-T cell therapy within 6 months before screening.
• People who received B-cell-depleting treatments (such as rituximab or similar therapies targeting CD19, CD20, or BAFF) within 6 months before screening, unless their B-cell levels have returned to normal or pre-treatment levels.
• People who received certain non-standard SLE treatments (such as Saphnelo/anifrolumab) within 3 months or 5 half-lives of that drug 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 an active infection (bacterial, viral, fungal, or other) within 14 days before screening.
• People who have had a severe allergic reaction (Grade 3 or 4) to another monoclonal antibody treatment, or who are known to be allergic to any ingredient in the trial drug CC312 (note: people who had a mild, short-lived reaction lasting 24 hours or less may be considered after discussion with the trial team).
• People with a history of drug, substance, or alcohol addiction.
• People who had major surgery within 4 weeks before screening, or minor surgery within 2 weeks before screening, where wounds have not fully healed (routine procedures such as catheter insertion are not included in this rule).
• People who had a significant heart-related event within 6 months before screening, including severe heart failure (NYHA Class III or IV), heart attack, unstable chest pain, or uncontrolled or significant heart rhythm problems.
• People with any other serious underlying illness, mental health condition, or personal circumstances that the trial team believes could interfere with safe participation or the reliability of the trial.
• People diagnosed with cancer within the past 5 years before screening.
• People who have had significant bleeding (Grade 2 or higher) within 30 days before screening, or who need to take long-term blood-thinning medications such as warfarin or similar drugs.
• People who are pregnant or breastfeeding.
• People who test positive at screening for tuberculosis (unless they have already completed adequate TB treatment and have no current symptoms), HIV, hepatitis B, hepatitis C, or syphilis.
• People who the trial investigator considers unsuitable for any other reason.

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