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 have been diagnosed with lupus (SLE) for at least 24 weeks before the screening visit, and your diagnosis meets specific classification guidelines.
• You have had at least one of certain lupus-related proteins (autoantibodies) detected in your blood — either a positive ANA test, or elevated anti-dsDNA or anti-Sm levels — within the past 12 months or at screening.
• Your lupus is currently active, shown by a specific disease activity score (SLEDAI) of 6 or higher at screening.
• Your lupus has not responded well enough to at least 2 prior treatments (such as steroids, antimalarials, immunosuppressants, or biologics), and at least one of those treatments must have been an immunosuppressant or biologic medication.
• If you are currently taking steroids and/or antimalarial medication, your dose must have been stable for a set period before the study starts.
• Your blood test results meet specific safety levels for white blood cells, red blood cells, platelets, kidney function, and liver function (confirm with trial site for exact values).
• For one part of the study only (Part B): you previously participated in Part A of the trial, tolerated the study drug well, and at least 90 days have passed since your last dose.

Who may not be able to join:

• You have another active inflammatory disease (other than lupus) — though thyroid inflammation or lupus-related dry eye/mouth syndrome is generally allowed.
• You are considered to be at high risk of developing blood clots.
• You have rapidly worsening kidney disease affecting the filters in your kidneys, or very high levels of protein in your urine.
• You are currently experiencing severe lupus-related problems affecting your brain or nervous system.
• You currently have, or show evidence of, hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus infection.
• You have previously had your spleen removed.
• You have previously received a cell therapy or gene therapy of any kind.
• You have taken another experimental treatment within 30 days (or longer, depending on the drug) before the study starts.
• You have received certain anti-B-cell therapies (anti-CD19 or anti-CD20) within the past 3 months.
• You have taken certain non-biologic disease-modifying drugs within the past 14 days, or certain immune-modifying biologic drugs within the past 2 months, or cyclophosphamide within the past month.
• You have received a live or weakened vaccine within 28 days before or during the screening period.
• You have had a significant active infection — including COVID-19 — within 14 days before the study starts.
• You have active or latent tuberculosis (TB), unless you have fully completed TB treatment in the past and have no current signs of TB.
• You have any other condition that the study doctor believes would make participation unsafe or unsuitable for you (confirm with trial site).

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