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 between 18 and 70 years old (inclusive), of any gender
• People who have been clinically diagnosed with Refractory Systemic Lupus Erythematosus (SLE)-related low platelet count (immune thrombocytopenia), confirmed by at least two blood tests showing very low platelet levels, normal-appearing blood cells under a microscope, and bone marrow results consistent with immune thrombocytopenia
• People whose condition has not responded adequately to at least one course of high-dose steroid treatment combined with one or more immune-suppressing medications taken for at least 3 months, or whose improvement could not be maintained when steroids were reduced
• People who are able to limit steroid use to a low dose (no more than 10mg of prednisone or equivalent) and stop all other immune-suppressing medications (except hydroxychloroquine) during the study
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the trial's preparatory treatment
• All participants who are capable of having children must agree to use effective contraception throughout the study and for at least 2 years after receiving the CAR-T cell infusion
• People whose liver, kidney, lung, and blood cell function meet the minimum levels required by the trial (confirm with trial site for specific values)
• People with an oxygen level above 91% without supplemental oxygen

Who may not be able to join:

• People with severe, active lupus affecting the brain or nervous system (such as seizures, psychosis, stroke, or inflamed blood vessels in the brain) requiring treatment within the 60 days before the trial baseline
• People currently on kidney dialysis, or whose kidneys are functioning at a very low level (creatinine clearance below 30mL/min)
• People who are pregnant or breastfeeding
• People with active, serious infections such as blood poisoning, uncontrolled lung infections, or active tuberculosis
• People who test positive for Hepatitis B (with active virus detected), Hepatitis C, HIV, or syphilis
• People who have had major surgery within 4 weeks before screening that the trial investigators consider makes participation unsuitable
• People with a currently active cancer diagnosed within the past five years (people with a past cancer that has been fully treated and cured may still be considered)
• People with certain heart conditions, including significantly reduced heart pumping function, severe heart failure, serious heart rhythm problems requiring treatment, abnormal heart electrical readings beyond set thresholds, or a heart attack, bypass, or stent procedure within the past 6 months (confirm with trial site for specific measurements)
• People with a significant build-up of fluid around the lungs detected at screening
• People who have received a live vaccine within 6 weeks before screening
• People who have had a blood clot in a deep vein within the past 6 months, or a history of a blood clot in the lungs
• People whose life expectancy is less than 6 months
• People who are currently participating in another interventional clinical trial or who have received an experimental treatment within 3 months (or within 5 half-lives for approved drugs) before the CAR-T cell infusion
• People with a history of epilepsy, stroke, brain bleeding, or other active neurological conditions affecting the brain or nervous system
• People with a known allergy or sensitivity to any component of the trial's CAR-T cell treatment (Inaticabtagene Autoleucel Injection)
• People who have previously received any CAR-T cell therapy

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