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NCT Number: NCT07403188

A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101

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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Key information

Conditions

Refractory Lupus Nephritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autoimmune Diseases of the Nervous System Central Nervous System Diseases Connective Tissue Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dermatomyositis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Joint Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Myasthaenia Gravis Myositis Nephritis Nervous System Diseases Neuromuscular Diseases Polymyositis Rheumatic Diseases Rheumatoid Arthritis (RA) Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Spinal Cord Diseases Stiff Person Syndrome Stiff-Person Syndrome Systemic Sclerosis (SSc) Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KYV-101

Drug

Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.

Primary outcomes

  1. Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

    Time frame: Up to 15 years from study entry

  2. Number of participants with new or recurrent malignancies as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

    Time frame: Up to 15 years from study entry

  3. 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).

    Time frame: Up to 15 years from study entry

  4. 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).

    Time frame: Up to 15 years from study entry

  5. Number of participants with new hematologic disorders as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

    Time frame: Up to 15 years from study entry

  6. Number of participants with new infections as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

    Time frame: Up to 15 years from study entry

  7. Number of participants with positive Replication-Competent Lentivirus (RCL) laboratory test results through Year 5 of long-term follow-up (LTFU).

    Time frame: Up to 5 years from study entry

  8. Number of participants with positive Chimeric Antigen Receptor (CAR) laboratory test results through Year 5 of long-term follow-up (LTFU).

    Time frame: Up to 5 years from study entry

  9. Number of participants with positive Anti-Drug-Antibody (ADA) laboratory test results through Year 5 of long-term follow-up (LTFU).

    Time frame: Up to 5 years from study entry

Secondary outcomes

  1. For lupus nephritis participants, number of participants administered glucocorticoids and other immunosuppressants through Year 2 after KYV101 infusion.

    Time frame: Up to 2 years from first KYV-101 infusion

  2. 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.

    Time frame: 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.

  3. For myasthenia gravis participants, change in score on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire through Year 5 of LTFU.

    Time frame: 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.

  4. For myasthenia gravis participants, change in score on the Quantitative Myasthenia Gravis (QMG) questionnaire through Year 5 of LTFU.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyverna Therapeutics

CONTACT

[email protected]

510-925-2484

Sponsors and collaborators

Lead sponsor

Kyverna Therapeutics

Industry

Registry information

Acronym: KYSA-4

Important dates

Study start
2025
Primary completion
2041
Study completion
2041
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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