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ALLO 329 CAR T cells (ALLO329) are immune cells from a healthy donor that are designed to find and remove immune cells that by mistake attack the body. The goal of this study is to find the highest safe dose of ALLO329 that can help reset the immune system and keep these health issues under control for a long time. Before joining the study, you will need to complete tests and assessments to see if you qualify. This may need more than one visit to the CU Anschutz campus. These visits will involve a physical exam, blood and urine tests, and a pregnancy test if needed. You will also answer questions about your health and complete tests to check your heart, such as a heart test which measures your rate and rhythm, a heart ultrasound, and a MUGA scan. Extra tests may be needed based on your condition. If you join the study, you will be placed in 1 of 3 treatment groups. You cannot choose your group. Depending on your group, you will get ALLO329 alone, cyclophosphamide before ALLO329, or cyclophosphamide and fludarabine before ALLO329. Before treatment starts, you will complete tests and assessments like those done during your first visit. After getting ALLO329, you may stay in the hospital for up to 4 days so the study team can closely check your health and any side effects. After you leave the hospital, you must stay within a 2 hour drive of the CU Anschutz campus for at least 35 days. After treatment, you will have follow up visits over the next 5 years to monitor your health. These visits may involve tests, procedures, and questionnaires. At the end of the 5 years, you will be asked to join a long term follow up study for an extra 10 years of safety monitoring. You and your insurance will be in charge of the cost of your normal health care visits. The study drug and study related procedures will be provided at no cost. You may earn up to $2,925 for completing all study visits. A caregiver (family member or friend) may earn up to $1,275 for taking you to these visits.

Who can Participate

You may be able to join this study if you are between 18 and 70 years old and have SLE, IIM, or SSc that is active after standard treatment, including at least 2 months of treatment with immunosuppressive medication. You may not qualify if you have had certain cancers within the past 5 years, received cell therapy or a transplant, or recently received a live vaccine.

Study ID

More information available at ClinicalTrials.gov: NCT07085104