The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).
This LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).
Provided informed consent for the LTFU study
Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol
Not applicable
Participants who received at least 1 infusion of KYV-101 in a previous KYV-101 treatment clinical study
Other
Prospective
KYV-101
DrugAutologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.
Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).
Number of participants with new or recurrent malignancies as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).
Number of participants with new or exacerbation of a pre-existing neurologic disorder as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).
Number of participants with new or exacerbation of a prior rheumatologic or other autoimmune disorder as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).
For lupus nephritis participants, number of participants administered glucocorticoids and other immunosuppressants through Year 2 after KYV101 infusion.
For stiff-person syndrome participants, change in time required (in seconds) to complete the Timed 25-foot Walk (T25-FW) through Year 4 of LTFU.
For stiff-person syndrome participants, change in time required (in seconds) from baseline to complete the Timed 25-foot Walk (T25-FW) test as assessed by the investigator through Year 4 of long-term follow-up (LTFU). The T25-FW test is a quantitative mobility and leg function performance test based on a timed 25-foot walk, with shorter times indicating better mobility and improved disease severity.
For myasthenia gravis participants, change in score on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire through Year 5 of LTFU.
For myasthenia gravis participants, change in score from baseline on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The MG-ADL questionnaire is a quantitative functional status instrument, with scores ranging from 0 to 24, with a higher score indicating worse disease severity.
For myasthenia gravis participants, change in score on the Quantitative Myasthenia Gravis (QMG) questionnaire through Year 5 of LTFU.
For myasthenia gravis participants, change in score from baseline on the Quantitative Myasthenia Gravis (QMG) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The QMG questionnaire is a quantitative muscle strength and endurance/fatigability instrument, with scores ranging from 0 to 39, with a higher score indicating worse disease severity.
Click on the lead sponsor to view all of their trials.
