Refractory Lupus Nephritis, Myasthaenia Gravis, Stiff Person Syndrome, Rheumatoid Arthritis (RA), Multiple Sclerosis, Dermatomyositis, Systemic Sclerosis (SSc)
Conditions
Brief summary
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).
Interventions
DRUGKYV-101
Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.
Sponsors
Kyverna Therapeutics
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU). | Up to 15 years from study entry |
| Number of participants with new or recurrent malignancies as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU). | Up to 15 years from study entry |
| 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). | Up to 15 years from study entry |
| 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). | Up to 15 years from study entry |
| Number of participants with new hematologic disorders as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU). | Up to 15 years from study entry |
| Number of participants with new infections as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU). | Up to 15 years from study entry |
| Number of participants with positive Replication-Competent Lentivirus (RCL) laboratory test results through Year 5 of long-term follow-up (LTFU). | Up to 5 years from study entry |
| Number of participants with positive Chimeric Antigen Receptor (CAR) laboratory test results through Year 5 of long-term follow-up (LTFU). | Up to 5 years from study entry |
| Number of participants with positive Anti-Drug-Antibody (ADA) laboratory test results through Year 5 of long-term follow-up (LTFU). | Up to 5 years from study entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For lupus nephritis participants, number of participants administered glucocorticoids and other immunosuppressants through Year 2 after KYV101 infusion. | Up to 2 years from first KYV-101 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. | Up to 4 years from study entry | 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. | Up to 5 years from study entry | 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. | Up to 5 years from study entry | 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. |
Countries
United States
Contacts
CONTACTKyverna Therapeutics
Outcome results
None listed