Early 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:

• People aged 18 to 65 years old (male or female) who are willing to take part and sign a consent form
• People who have previously been diagnosed with systemic lupus erythematosus (SLE), a type of autoimmune disease, based on a specific set of recognised diagnostic guidelines from 1997
• Women who could become pregnant must use effective birth control during the study and for 90 days after the last treatment dose, and must not donate eggs during this same period
• People whose SLE is currently quite active, as measured by a specific disease activity scoring tool called SLEDAI-2K, with a score of 8 or above before the screening visit
• People whose SLE is significantly affecting at least one body system, or moderately affecting at least two body systems, as measured by another scoring tool called BILAG-2004, before the screening visit
• People who have at least one of the following blood test results: a positive antinuclear antibody (ANA) test at a level of 1:80 or higher; anti-double-stranded DNA antibodies above the normal range; or anti-Smith antibodies above the normal range
• People with blood counts and heart function within certain minimum ranges — specifically, a neutrophil count (a type of white blood cell) of at least 1.0×10⁹/L, a haemoglobin level (a measure of red blood cells) of at least 60g/L, and a heart pumping function (called left ventricular ejection fraction) of at least 50%
• People who have been taking steroid tablets combined with an immune-suppressing or biological medication for at least 6 months before joining the trial

Who may not be able to join:

• People with known severe allergies or reactions to any of the medications used in this trial, including cyclophosphamide, fludarabine, or obinutuzumab
• People who currently have an active infection being treated with intravenous (drip) antibiotics, or who received intravenous antibiotics within one week before the cell treatment
• People who have an immune deficiency condition, whether inherited or acquired (such as HIV)
• People with severe heart failure classified as Grade III or IV under standard medical guidelines
• People with a history of epilepsy or other diseases affecting the brain or nervous system
• People with a history of serious herpes infections, such as herpes affecting the brain, the eyes, or spread widely across the body
• People with a history of most other cancers, except for certain skin cancers that were fully treated with surgery, or certain other cancers (such as cervical, superficial bladder, or breast cancer) that are considered fully cured
• People who had signs of chickenpox or shingles infection within the 12 weeks before screening, or people with a significant history of heart, hormone, blood, liver, immune, metabolic, lung, nerve, skin, psychiatric, or kidney conditions that the treating doctor considers would make the cell treatment unsafe (conditions caused by lupus itself are assessed separately)
• Women who are pregnant, breastfeeding, or planning to become pregnant within six months
• People with an active skin condition that could make it difficult to assess lupus skin symptoms, including conditions such as psoriasis, dermatomyositis, systemic sclerosis, or certain other skin diseases not caused by lupus
• People who have taken part in another clinical trial within the past 3 months
• People who have received any treatment specifically targeting B cells (a type of immune cell) within 1 month before joining
• People whose blood test results are considered by the study doctor to be significantly abnormal in a way that would make participation unsafe
• People where the study doctors judge that participation may increase health risks or affect the reliability of the trial results

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