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:

General requirements (all participants):

• Adults aged 18 to 75 years old
• Willing and able to sign a consent form and follow the study schedule and requirements
• Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use birth control or abstinence from 2 weeks before the first dose until 1 year after the last dose
• The disease has continued to worsen even while taking the highest tolerated doses of blood pressure/kidney-protecting medications (called RAS blockers)
• People taking steroid medications long-term for their condition must be on a dose of prednisone (or equivalent) of no more than 20 mg per day, and that dose must have been stable for at least 14 days before the study screening begins
• People taking immune-suppressing or immune-modifying medications (other than steroids) must have been on a stable dose for at least 4 weeks before screening

For people with Lupus Nephritis (LN) specifically:

• A diagnosis that scores 10 or more points on the standard medical classification system for lupus (ACR 2019 criteria)
• A kidney biopsy — taken during the screening period or within the past 6 months — that confirms active lupus nephritis of a specific type (Class III or Class IV, without Class V overlap), with at least mild to moderate disease activity and no more than moderate scarring
• Significant protein in the urine, measured within a specific range (confirm with trial site for exact values), indicating active kidney disease
• At least one of the following blood test results: a positive ANA test at a certain level, a positive anti-double-stranded DNA (anti-dsDNA) test, or a positive anti-Smith (anti-Sm) antibody test
• The lupus nephritis has not responded well enough to at least 2 prior treatments (each involving immune-suppressing or modifying medications with steroids, given at full therapeutic doses for at least 90 days each)

For people with Primary Membranous Nephropathy (pMN) specifically:

• A kidney biopsy — taken during screening or within the past 6 months — that confirms primary membranous nephropathy
• Significant protein in the urine indicating active kidney disease (confirm with trial site for exact values)
• Specific antibodies in the blood associated with primary membranous nephropathy
• The condition either did not respond well enough to at least one prior course of treatment (not reaching full remission within 180 days, or partial remission within 90 days), or the person was unable to tolerate that treatment

Who may not be able to join:

General reasons (applying to all participants):

• Kidney function that is too low, based on a standard measure called eGFR (below 45 ml/min/1.73m²)
• Currently on kidney dialysis, or expected to need dialysis during the study
• A history of receiving a solid organ transplant or bone marrow/stem cell transplant, or a planned transplant during the study period
• A condition — either present from birth or developed later — that causes serious problems with the immune system and leads to severe infections, or currently receiving regular immunoglobulin replacement therapy
• Significant liver disease or abnormal liver blood test results above a certain level
• Certain lung conditions, including COPD or asthma requiring daily oral steroids, low oxygen levels at rest, or a significant smoking history combined with active lung disease
• Certain blood count abnormalities (such as low white blood cells, low red blood cells, low neutrophils, or low platelets) that are not caused by the condition being studied
• Significant heart problems, including any of the following:
  • Uncontrolled chest pain (angina) or dangerous heart rhythm problems
  • A heart attack within the 12 weeks before the first dose
  • Any previous coronary artery bypass graft (open heart) surgery
  • Moderate-to-severe heart failure or significantly reduced heart pumping function
  • An abnormal heart rhythm measurement on an ECG above a certain level
  • Certain blood clot events (such as pulmonary embolism) or blood vessel bypass surgery within the 12 weeks before the first dose
  • High blood pressure that remains uncontrolled (above 160/90 mmHg) despite treatment
• Active bleeding disorders
• Another autoimmune condition — or its treatment — that could interfere with study results; a condition that could cause secondary kidney disease (such as certain infections, liver disease, tumours, or medications); or a kidney biopsy showing a significant kidney disease other than the one being studied (note: some overlapping conditions such as Sjögren's syndrome or rheumatoid arthritis may not automatically exclude someone — confirm with trial site)
• Currently pregnant, breastfeeding, or not using adequate contraception (for those who could become pregnant)
• A current infection being treated with systemic antibiotics or antiviral medication, or a recent serious infection treated this way within the past 30 days
• A positive HIV test (past or at screening), active or latent tuberculosis requiring treatment, or positive Hepatitis B or C test at screening
• Major surgery within 28 days before the first dose, or surgery from which full recovery has not yet occurred
• A cancer diagnosis within the past 5 years (some exceptions may apply for certain skin cancers or treated cervical abnormalities — confirm with trial site)
• Previous treatment with certain cell-based therapies, including CAR-T cells, CAR-NK cells, or mesenchymal cell therapy
• Certain nervous system conditions or autoimmune diseases affecting the brain or nervous system within 90 days before the first dose, or active lupus affecting the brain or nervous system within the past year
• Any other significant medical or psychiatric condition, or abnormal test result, that the study doctor believes would interfere with participation
• Currently enrolled in another clinical trial involving an investigational treatment (people who have finished such a trial may be considered after a sufficient waiting period — confirm with trial site)
• Currently taking, or known to need, any medications that are not permitted under the study protocol
• A known allergy or medical reason to avoid the study treatment or its components (including human serum albumin or dimethyl sulfoxide)

For people with Lupus Nephritis (LN) specifically:

• A known, clinically active diagnosis of antiphospholipid antibody syndrome (APS), or a blood test profile considered high-risk for this condition

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