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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511198-31-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KYV-101 | Drug | Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product. |
|
| Measure | Description | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who received at least 1 infusion of KYV-101 in a previous KYV-101 treatment clinical study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyverna Therapeutics | Contact | 510-925-2484 | clinicaltrials@kyvernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Denver | Recruiting | Denver | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D016750 | Stiff-Person Syndrome |
| D001172 | Arthritis, Rheumatoid |
| D009103 | Multiple Sclerosis |
| D003882 | Dermatomyositis |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
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. |
| Up to 4 years from study entry |
| 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. | Up to 5 years from study entry |
| 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. | Up to 5 years from study entry |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D003711 | Demyelinating Diseases |
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D012871 | Skin Diseases |