Early 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:

• Adults aged 18 or older.
• People whose kidneys are affected must have kidney function at or above a certain level (an eGFR of at least 15 mL/minute/1.73 m²).
• People whose blood test results, taken within 3 days before a specific cell collection procedure, meet minimum levels for: lymphocytes (a type of white blood cell), neutrophils (another type of white blood cell), platelets, and haemoglobin (a measure of red blood cells) — with some restrictions on recent transfusions or certain medicines before testing.
• People whose kidney filtration rate (measured by a specific formula) is at or above a certain level (at least 30 mL/min).
• People whose liver-related blood test results (bilirubin, liver enzymes AST and ALT) fall within acceptable ranges, with a possible exception for people with a specific inherited condition affecting bilirubin (confirm with trial site).
• People whose blood clotting test results fall within acceptable ranges.
• People who are willing to sign a consent form agreeing to take part.
• People of childbearing potential who agree to use effective contraception from signing the consent form until one year after receiving the study treatment, and women of childbearing potential whose pregnancy test is negative at screening and before cell infusion.
• People, or their legal guardians, who understand the study's purpose and procedures and agree to participate.

For the lupus nephritis (LN) part of the trial, people must also:

• Have been diagnosed with systemic lupus erythematosus (an immune system disease that can affect many organs) according to 2019 specialist guidelines, and have had a kidney biopsy within the 6 months before treatment confirming an active, inflammatory form of lupus affecting the kidneys (specific types: III, IV, III/IV, or V), and have already tried standard treatments that either did not work or the condition came back after improving.
• Have a positive result on certain immune-related blood tests (ANA and/or anti-dsDNA antibodies) at screening.
• Have a disease activity score (SLEDAI-2000) of 8 or higher at screening, or a clinical score of 6 or higher with certain abnormal blood markers present (confirm with trial site).

For the IgG4-related disease (IgG4-RD) part of the trial, people must also:

• Have been diagnosed with IgG4-RD according to 2019 specialist guidelines.
• Have a condition that keeps coming back or has not responded to previous treatments.
• Have an active disease score (IgG4-RD response index) of 2 or higher.
• Have a specific pattern of the disease affecting certain glands or multiple organs (confirm with trial site).

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have had a cancer diagnosis within the past 5 years — though some exceptions may apply for certain fully treated, non-recurring cancers (such as some skin cancers, cervical carcinoma in situ, certain prostate cancers, or thyroid cancer with no active disease) (confirm with trial site).
• People who have received certain medicines that reduce B-cells (a type of immune cell) — such as rituximab or similar drugs — in the 6 months before the CAR-T cell infusion, unless tests show B-cells have returned to normal levels.
• People who have received immune-suppressing medicines, or steroid medicines above a certain dose, within 3 days before the CAR-T cell infusion.
• People who have received a live vaccine within 2 weeks before screening.
• People with active or chronic hepatitis B (unless the virus level is very low), hepatitis C, HIV, or syphilis.
• People with an active infection currently requiring intravenous (drip) antibiotics or hospital admission.
• People with significant heart problems, including: very high levels of a specific heart stress marker in the blood, the most severe level of heart failure, or a heart attack, severe chest pain requiring hospitalisation, or certain heart procedures (stent or bypass surgery) within the past 6 months.
• People who are known to be allergic or intolerant to any ingredient in the study treatment (PRG-1801) or to medicines that may be used during the study, including fludarabine, cyclophosphamide, or albumin, or who have had a severe allergic reaction to these before.
• People who the trial doctors consider unsuitable for the cell collection or infusion process, or for any other reason unsuitable for the study.

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