Phase 2 Vasculitis 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 90 years old.
• People who have been classified as having Systemic Lupus Erythematosus (SLE) based on a recognised scoring system (EULAR/ACR 2019 criteria), with a total score of 10 or higher.
• People whose lupus disease activity score (SELENA-SLEDAI) is 8 or higher, indicating active disease.
• People who have a specific type of immune cell called CD19+ B-cells present in their blood.
• People whose blood test results meet minimum levels for haemoglobin, white blood cells, neutrophils, and platelets (confirm specific values with trial site).
• People whose liver and kidney function test results are within acceptable ranges, and whose heart pumping function (ejection fraction) is at least 50% on an echocardiogram (heart scan).
• People who have suitable veins for a blood cell collection procedure called leukapheresis, with no medical reasons preventing this.
• Women who could become pregnant must have a negative pregnancy test at the start of the trial.
• People who agree to use effective contraception during the trial and for at least one year after receiving the CAR-T cell treatment.
• People who agree to attend all required follow-up appointments.
• People who have given their voluntary written consent to participate, or whose legal representative has done so on their behalf.

Who may not be able to join:

• People with severe lupus-related kidney disease, including those who need dialysis or whose kidney function (measured by a specific blood test) is below a certain threshold within 8 weeks before the cell collection procedure.
• People with certain brain or nervous system conditions, including epilepsy, psychosis, stroke, encephalitis, brain vasculitis, or depression or suicidal thoughts.
• People with serious existing damage or disease affecting major organs such as the heart, liver, kidneys, blood, or endocrine (hormone) system.
• People with immune deficiency conditions, uncontrolled active infections, or active or recurring stomach or intestinal ulcers.
• People who have received immune-suppressing medications within 1 week before the cell collection procedure.
• People who have HIV, or an active hepatitis B or hepatitis C infection.
• People who have a syphilis infection.
• People who have an active fungal, bacterial, viral, or other infection that cannot be controlled at the time of screening.
• People who have received a live vaccine within 4 weeks before screening.
• People with severe allergies or hypersensitivity reactions.
• People who have a medical reason they cannot receive the conditioning medications cyclophosphamide or fludarabine.
• People who have had major surgery within 2 weeks before signing the consent form, or who are expected to need surgery (other than minor local anaesthetic procedures) during the trial or within 2 weeks of receiving the treatment.
• People who have tubes or drains in place other than a central venous catheter.
• Women who are pregnant or breastfeeding, or people who plan to have children within 1 year of receiving the treatment.
• People who have previously received therapy targeting CD19 or BCMA.
• People who have participated in another clinical trial within the past 3 months.
• People with a current or prior cancer diagnosis, with some exceptions including certain skin cancers, cervical carcinoma in situ, bladder cancer, and breast cancer (confirm details with trial site).

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