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:

• You are between 18 and 65 years old at the time of signing the consent form.
• You are willing and able to give written consent to participate voluntarily.
• You have been officially diagnosed with Systemic Lupus Erythematosus (SLE) for at least 6 months, confirmed by medical records.
• You currently have, or have previously had, certain specific antibodies in your blood associated with SLE (called anti-dsDNA and/or anti-Smith antibodies).
• Your liver function blood test results are within an acceptable range (confirm with trial site).
• You are not currently experiencing uncontrolled blood clotting problems that require regular treatment with clotting products; however, if you have been on a stable blood-thinning medication for more than 6 months with acceptable test results, you may still qualify (confirm with trial site).
• You do not have any serious uncontrolled other illnesses or active infections.
• (For one group of participants) You have a confirmed kidney disease related to SLE, proven by a biopsy, classified as a specific severity level (Class III or IV, with or without Class V overlap) (confirm with trial site).
• (For another group of participants) Your SLE is active and scored above a certain threshold on standard medical disease activity scales, affecting specific areas such as the heart, lungs, blood, or joints (confirm with trial site).

Who may not be able to join:

• You are currently pregnant or breastfeeding.
• Your SLE is severely affecting your brain or nervous system at the highest severity level on a standard medical scale (confirm with trial site).
• You are currently experiencing a sudden, severe SLE flare-up that needs immediate treatment, such as acute inflammation around the heart, a serious blood clotting condition, or active brain-related lupus symptoms like seizures or psychosis.
• Your lupus was caused by a medication rather than occurring on its own naturally.
• You are currently receiving kidney dialysis (either hemodialysis or peritoneal dialysis).
• You have previously had a bone marrow transplant, gene therapy, or any type of CAR T-cell therapy (a specialised immune cell treatment).
• You have a current or previous diagnosis of HIV.
• You currently have active Hepatitis B or Hepatitis C infection (note: certain people with past exposure but no active virus may still be eligible — confirm with trial site).
• You have a known allergy to certain medications used to manage side effects of CAR T-cell therapy, such as tocilizumab.
• You have an ongoing neurological or significant psychiatric condition that could make it difficult to safely monitor certain treatment side effects (confirm with trial site).
• You have another serious or uncontrolled medical condition that the trial doctor believes would put you at unacceptable risk or interfere with the trial.
• You have had major surgery within the 12 weeks before starting treatment, or are planning major surgery during the trial period, and the trial doctor considers this to be a significant risk.
• You are currently receiving treatment as part of another clinical trial.

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