A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

This study is for people between 12 and 70 years old who have certain autoimmune diseases that affect the body's B-cells. This includes lupus (with or without kidney problems), ANCA-associated vasculitis, idiopathic inflammatory myositis, or systemic sclerosis. Your condition must be active and moderate to severe, meaning that at least two other previous treatments haven't worked well enough for you. You also need to be generally healthy enough to go through the study treatments and procedures.

There are certain reasons why someone wouldn't be able to join. For example, if you are pregnant or breastfeeding, you cannot participate. People with severe problems with their heart, lungs, liver, or kidneys are also not able to join. You can't have any serious infections right now or have had them very recently. If you've had certain cancers recently, specific cell therapies (like CAR T-cell therapy), or an organ transplant, you wouldn't be eligible. Also, you must not have any known allergies to the medicines used in the study and need to weigh at least 50 kilograms (about 7 stone 12 pounds).

If you decide to take part, you'll first be carefully checked to make sure you meet all the study requirements. Once enrolled, you'll receive the study medicine, FT819, which might be given with other supporting medicines. You'll have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and see how you're responding to the treatment. This will involve physical exams, having blood samples taken, and possibly some scans. The study will start with a stage where different doses are tested, followed by a stage where more people receive the best dose. We expect your total involvement in the study to last for a certain period, which your study doctor will explain fully. They will also tell you about any follow-up visits after you finish taking the medicine.