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:

• You are between 18 and 70 years old (70 is included)
• If your kidneys are affected, they must still be working at a minimum level as measured by a specific kidney function test (eGFR ≥ 15 mL/min/1.73m²)
• Your recent blood test results meet certain minimum levels for white blood cells, platelets, red blood cells, and kidney and liver function (confirm with trial site for exact values)
• You are willing to sign a consent form agreeing to take part
• For people with ANCA-associated vasculitis (AAV): You have been diagnosed with a specific type of blood vessel inflammation (GPA or MPA subtype) according to 2022 medical guidelines, your condition has not gone into remission after at least 3 months of standard treatment, or it has come back after maintenance therapy, and your disease is currently active and serious
• For people with lupus nephritis (LN): You have been diagnosed with lupus and a kidney biopsy within the last 6 months confirmed an active, specific type of kidney inflammation (type III or IV, or a combination with type V), standard treatments have not worked or your condition has returned after remission, certain lupus-related antibodies are present in your blood, your lupus disease activity score is high enough, and your expected survival is at least 3 months

Who may not be able to join:

• You are currently pregnant or breastfeeding
• You have lung bleeding (alveolar hemorrhage) that requires a breathing machine to support your breathing
• You have another autoimmune disease alongside your vasculitis, such as lupus, rheumatoid arthritis, or certain other conditions
• You have lupus with severe complications affecting the brain, lungs, heart, or gut, or you have another autoimmune disease alongside your lupus
• You have a known allergy or serious reaction to any ingredient in the study treatment (PRG-1801) or related drugs used in the study, including fludarabine, cyclophosphamide, tocilizumab, or albumin
• You have been diagnosed with cancer in the last 5 years (some exceptions may apply for certain fully removed skin or cervical cancers — confirm with trial site)
• You have serious heart problems, such as severe heart failure, very high heart stress markers in your blood, or a recent heart attack, unstable chest pain, or heart procedure within the last 6 months
• You have recently received certain medications within specific timeframes before the study, including rituximab (within 24 weeks), certain other biological drugs (within 4 weeks), immunosuppressants (within 2 weeks), high-dose steroids, plasma exchange, or intravenous immunoglobulin — confirm exact timeframes with trial site
• You have received a live or weakened (attenuated) vaccine within 4 weeks before the study or plan to during the study
• You have active hepatitis B with high virus levels in your blood, hepatitis C, HIV, or syphilis
• You currently have an active infection that needs intravenous antibiotics or hospital treatment
• You have had major surgery within 4 weeks before joining
• You have another serious or uncontrolled health condition that the trial doctor feels could interfere with the study
• You have taken part in another clinical trial within the last 3 months, or within 5 times the half-life of the trial drug (whichever is longer)
• The trial doctor determines for any other reason that you are not suitable for the treatment or the study

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