The purpose of the study is to evaluate the safety of FT018 in people with HIGM1. The study is open label, which means that both the study team and the participants know which treatment is being given, and it has one treatment group. The treatment course includes one or more infusions of the modified cells, followed by regular follow-up visits over time to watch for side effects, signs of immune system recovery, infections, and overall health. Some participants may receive an additional dose later if needed.

The study also includes several background vaccines used as standard care, including Rabipur, TICOVAC, and Infanrix hexa. These are vaccines against rabies, tick-borne encephalitis, and a group of childhood infections including diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b. The study follows people for up to 2 years after treatment.

The purpose of this study is to assess the long-term safety and how well the body tolerates leniolisib when used to treat immune problems in people with primary immunodeficiency. This is an extension study, which means it is designed for people who have already participated in earlier studies of this medication and who their doctors believe would benefit from continuing to take leniolisib. The study will monitor for any unwanted effects or side effects through regular check-ups, vital sign measurements, safety laboratory tests, and physical examinations.

During the study, participants will continue taking leniolisib for an extended period, with the treatment lasting up to 156 weeks. The study will track various health measures over time, including blood cell counts such as hemoglobin, platelets, and different types of white blood cells. Doctors will also monitor lung function through breathing tests and imaging scans, check for changes in lymph nodes and spleen size, and measure certain substances in the blood that indicate how the immune system is functioning. All of these measurements help researchers understand how well the medication works over a long period and whether it remains safe for continued use.

The purpose of the study is to compare how the body processes these treatments and to assess their safety and tolerability in individuals aged 16 years and older with PIDD. Participants will receive both treatments at different times during the study. The study will monitor how the treatments are absorbed and used by the body, as well as any side effects that may occur. The study will also look at how often participants experience infections and how these affect their daily lives.

Participants will be involved in the study for a period of up to 27 weeks. During this time, they will receive regular infusions of the study medications and attend scheduled visits for monitoring. The study aims to provide valuable information on the effectiveness and safety of TAK-881 compared to HyQvia in managing Primary Immunodeficiency Diseases.

The purpose of this study is to evaluate how safe and tolerable TAK-881 is for people with PIDD over a long period. Participants in the study will receive the treatment through a method called subcutaneous infusion, which means the solution is slowly delivered under the skin using a small needle. The study will monitor participants for any side effects or reactions to the treatment, as well as how well the treatment helps in reducing infections and improving overall health. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups to assess their health and any changes in their condition. The study will also gather information on how the treatment affects the participants’ quality of life, including their ability to perform daily activities and their satisfaction with the treatment. The study aims to provide valuable information on the long-term use of TAK-881 for managing Primary Immunodeficiency Diseases.

Participants in the study will receive Newnorm once a week. The study aims to ensure that this weekly treatment maintains levels of a protein called immunoglobulin G (IgG) in the blood, which helps protect against infections, at levels similar to those achieved with less frequent treatments. The study will last for about a year, during which the safety and effectiveness of Newnorm will be closely monitored. Researchers will look at how often serious infections occur, how quickly infections resolve, and other factors like the use of antibiotics and hospital visits due to infections.

Throughout the study, participants will be asked to provide information about their health and any infections they experience. This will help researchers understand the impact of Newnorm on their quality of life, including time lost from work or school due to illness. The study is designed to gather important information that could lead to better treatment options for people with primary immunodeficiency diseases.

The purpose of the study is to determine if higher doses of immunoglobulin can better protect against the progression of lung disease in people with PAD. Participants will receive either a standard dose or a higher dose of immunoglobulin. The study will monitor the health of participants over time, focusing on lung health and the number of respiratory infections they experience. The study will also look at the overall health costs and quality of life for participants.

Throughout the study, participants will have regular check-ups and may undergo tests such as CT scans to assess lung health. They will also keep a diary to track any respiratory symptoms and report any missed days from work or school due to illness. The study aims to provide valuable information on the effectiveness and cost-efficiency of different dosing strategies for managing PAD and its impact on lung health.