Phase 2 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 70 years old at the time of giving consent.
• People who have been diagnosed with systemic lupus erythematosus (SLE) using a recognised 2019 international classification system, with a score meeting the required threshold.
• People whose lupus is currently active and has not responded well to previous treatments, based on specific disease activity scoring tools or the presence of active kidney involvement with certain markers in blood or urine.
• People whose lupus has not responded adequately to at least two previous standard treatments, including at least one medication that suppresses the immune system or a biologic therapy used for lupus or lupus kidney disease.
• People whose disease shows specific biological markers that match one of the two treatment arms in this trial — one arm targets a protein called CD19 (linked to certain immune cells), and the other targets a protein called BCMA (linked to a different type of immune cell or ongoing disease activity after previous treatment).
• People with active lupus kidney disease who have had a kidney biopsy confirming a specific type of lupus kidney involvement within the past 24 months, or where a doctor has confirmed that another biopsy would be too risky but the clinical picture strongly suggests active kidney involvement (confirm with trial site).
• People whose blood counts and organ function meet minimum required levels — including red blood cells, white blood cells, platelets, liver function, kidney filtration rate, and heart function — as assessed by the trial site.
• People who have suitable veins and are medically suitable for a procedure that collects certain immune cells from the blood (called leukapheresis).
• People who have a negative pregnancy test and who agree to use reliable contraception for 12 months after receiving the trial treatment.
• People who are able to stop certain lupus medications according to the trial's washout rules, and who are willing to stay in hospital for an observation period and attend long-term follow-up appointments.
• People who are able to give written informed consent.

Who may not be able to join:

• People who have an active infection that is not under control, including active tuberculosis, active hepatitis B or C, or HIV.
• People who have previously received CAR-T cell therapy or any treatment that targeted the CD19 or BCMA proteins using cell therapy.
• People who have severe active lupus affecting the brain or nervous system that requires urgent treatment, an uncontrolled seizure disorder, or who have had a stroke within 60 days before the screening visit.
• People who have advanced organ failure that is not expected to improve, such as kidney failure requiring dialysis, severe uncontrolled heart failure, or breathing instability requiring intensive care.
• People who currently have cancer, or who have had cancer within the past 5 years — with some exceptions for certain low-risk or fully treated skin cancers or early-stage cervical changes, as assessed by the trial site.
• People who are pregnant or breastfeeding.
• People who have previously had a bone marrow or stem cell transplant from a donor, or a solid organ transplant (such as a kidney or liver transplant).
• People who cannot receive certain medications used in this trial, including fludarabine, cyclophosphamide, or standard treatments for serious side effects that may occur.
• People who have received a live vaccine within 4 weeks before the lymphodepletion stage of the trial.
• People who are currently taking part in another interventional clinical trial, or who have done so within the 3 months before enrolling.
• People with an uncontrolled mental health condition, active substance misuse, or personal circumstances that may make it difficult to follow the trial requirements.
• People whose doctor judges that taking part would be unsafe or would make it difficult to interpret the trial results.

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