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 at the time of screening, of any gender.
• People who have been diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
• People whose SLE has not responded to standard treatments, including steroids, immune-suppressing medications, and biological therapies — specifically, people whose disease did not improve with at least two different non-steroid immune-suppressing treatments, at least one of which was a B-cell-targeting biological drug such as belimumab or rituximab (unless the treating doctor considers those drugs unsuitable or they were not available).
• People who test positive during screening for at least one lupus-related autoantibody, such as ANA at a level of 1:80 or higher, anti-dsDNA, anti-Sm, or other related autoantibodies above the normal range.
• People who have active SLE with a disease activity score (SLEDAI-2K) of 6 or higher, with or without kidney involvement, or people who have severe SLE-related low platelet counts (below 30×10⁹/L, or below 50×10⁹/L with signs of bleeding).
• People whose bone marrow, liver, and kidney functions meet minimum levels during screening (excluding any abnormalities caused by SLE itself) — confirm specific values with the trial site.
• Women of childbearing potential who test negative for pregnancy within 7 days before enrolling, are not breastfeeding, and agree to use approved contraception or abstain from sex during treatment and for at least 12 months after treatment ends; male participants whose partners could become pregnant must also agree to the same contraception requirements.
• People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.

Who may not be able to join:

• People with a current or past history of certain brain or nervous system conditions, such as seizures, stroke, paralysis, dementia, Parkinson's disease, encephalitis, brain injury, or serious mental illness — though people whose lupus-related epilepsy has been stable with no seizures for at least one year before screening may still be considered (confirm with trial site).
• People who have needed dialysis or high-dose steroid treatment (prednisone at 1.5 mg/kg/day or equivalent for 14 days or more) within the two months before screening.
• People with large, uncontrolled fluid build-up in body cavities (such as around the lungs or in the abdomen) that has not responded to treatment.
• People who have had another active autoimmune disease — such as Crohn's disease or rheumatoid arthritis — in the two years before screening, not including SLE-related conditions, autoimmune thyroid disease, or secondary Sjögren's disease.
• People with bone marrow problems that are not related to SLE or SLE-related low platelets, or people who have had or are waiting for a stem cell, bone marrow, or organ transplant.
• People who have previously received gene-modified cell therapies, such as CAR-T, CAR-NK, or TCR-T cell treatments.
• People who have taken part in another SLE drug trial within four weeks before screening.
• People who test positive for hepatitis B (with detectable virus in the blood), hepatitis C (with detectable virus in the blood), HIV, or syphilis.
• People with severely uncontrolled high blood pressure in the month before screening, or with certain serious heart conditions in the six months before screening, including significant irregular heart rhythms, heart failure, heart attack, or other clinically significant heart disease (confirm specific values with trial site).
• People who have had a blood clot in a vein or lungs within six months before screening, have significant fluid around the lungs, or have blood oxygen levels below 92% while breathing normal air.
• People with a history of most cancers diagnosed or treated within five years before screening — some early-stage or low-risk cancers may be excluded from this restriction (confirm with trial site).
• People with any active infection, or who have needed antibiotic or antiviral treatment for an infection in the 30 days before screening.
• People who, in the opinion of the trial doctor, have any other factor that could put them at risk, affect their ability to follow the treatment plan, or interfere with the study.

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