Long-Term Safety Evaluation of KYV-101 in Patients with Lupus Nephritis, Systemic Sclerosis, Myasthenia Gravis, Rheumatoid Arthritis, or Stiff Person Syndrome

The primary objective of this study is to evaluate the long-term safety of KYV-101 in participants previously treated for conditions including lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome. This assessment is intended to monitor for delayed adverse events following treatment. The study also evaluates the efficacy of the investigated intervention.

This study involves a total of 100 patients. The study population includes both male and female individuals within the age range of 18 to 44 years. Participants are diagnosed with conditions such as lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome. A primary inclusion requirement is that subjects must have received at least one infusion of KYV-101 as part of a previous parent treatment protocol. The main objective is to evaluate the long-term safety following treatment with KYV-101.

This long-term follow-up study is designed to evaluate the long-term safety of KYV-101 in individuals previously treated with the investigational product. The study population consists of participants who have received at least one infusion of KYV-101 as part of a prior parent treatment protocol for conditions such as lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome. No investigational medicinal product will be administered during this phase. The primary objective is to monitor the incidence of adverse events, specifically focusing on the development of new malignancy, exacerbation of pre-existing neurologic disorders, or new autoimmune disorders. Additional assessments include monitoring for hematologic disorders, injection-site reactions, the persistence of the product as assessed by ddPCR, and the incidence of replicating competent lentivirus via qPCR. The study is expected to continue through December 31, 2042.

The experimental medication is KYV-101, which is provided in a suspension pharmaceutical form. This substance is administered via infusion.

The assessment of efficacy in this long-term follow-up study is focused on specific clinical and molecular parameters. The primary evaluation includes the incidence of adverse events, specifically the development of new malignancy or the exacerbation of pre-existing neurologic disorders. Additionally, the study monitors the new incidence or exacerbation of prior rheumatologic disorders, autoimmune disorders, or hematologic disorders.

Molecular monitoring is conducted to assess the persistence of KYV-01 using droplet digital PCR. The incidence of replication competent lentivirus is also evaluated via quantitative polymerase chain reaction.