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Recruiting NCT07403188

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

— Observational Refractory Lupus Nephritis Myasthaenia Gravis Stiff Person Syndrome Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KYV-101.
Who it may be relevant to
Registry conditions: Refractory Lupus Nephritis, Myasthaenia Gravis, Stiff Person Syndrome, Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug KYV-101
    Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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 outcome measures (4)
  • 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]
  • 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 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 on the Quantitative Myasthenia Gravis (QMG) questionnaire through Year 5 of LTFU. [Time frame: Up to 5 years from study entry]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • University of Colorado, Denver — Denver

Identifiers

NCT: NCT07403188 · KYV101-004 · 2024-511198-31-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗