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Vasculitis is a health problem where the blood vessels become inflamed. When this happens, blood may not flow properly and can damage the body’s organs. GPA and MPA are two types of vasculitis that are treated with a drug called Rituzimab. YTB323 is a new cell therapy treatment that uses modified immune cells to find and remove other immune cells called B cells, which are believed to play a role in causing vasculitis. Researchers do not yet know if YTB323 can help treat GPA and MPA better than Rituximab. If you are interested in joining this study, you will have an in-person visit. At this visit, the study team will ask about your health and medical history, and do a physical exam. You will also give some urine and blood for testing. You will complete a heart test called an ECG (electrocardiogram) and CT scan. If you qualify for the study and are one of the first six people to join, you will get YTB323. If you join after the first six people, you will get either YTB323 or Rituximab by chance, like flipping a coin. Both YTB323 and Rituximab are given via injections into a vein. Before getting YTB323, you will stop taking your current vasculitis medication, lower your steroid dose, have your immune cells collected to make YTB323, and get a 3-day, low-dose chemotherapy. You will get YTB323 after you get the chemotherapy. Afterwards, you will stay in the hospital for at least two weeks so that the study team can monitor your health and make sure you are doing okay. If you are getting Rituximab, you will get two injections of Rituximab two weeks apart. If you get YTB323 you will have 2 to 6 study visits, a 2-week hospital stay, and 18 follow-up visits. If you get Rituximab, you will have 15 study visits and one follow-up visit. You will be in this study for about two to six years. You and your insurance will need to pay for your routine medical care. You can earn up to $912 if you are in the YTB323 group or $684 if you are in the Rituximab group.

Who can Participate

You may be able to join this study if you are 18 to 75 years old and have GPA or MPA. You may not be able to take part if you have hepatitis B or C, HIV, or another autoimmune disease that requires treatment. You also may not be able to take part if you are pregnant, breastfeeding, planning to become pregnant or breastfeed, or your organs do not work well.

Study ID

More information available at ClinicalTrials.gov: NCT06868290