Actively Recruiting
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
Led by Kyverna Therapeutics · Updated on 2026-02-11
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on people who have previously been treated with KYV-101, an autologous CAR T cell therapy, to monitor long-term safety and persistence of the treatment. It aims to collect information about delayed side effects and ongoing presence of the gene-modified cells in participants who received at least one infusion of KYV-101 in earlier clinical trials sponsored by Kyverna Therapeutics. Participants in this observational study will continue to be followed for up to 15 years after their initial KYV-101 treatment. The study will track various health outcomes including treatment-related adverse events, new or returning malignancies, neurological and autoimmune conditions, blood disorders, infections, and specific laboratory tests related to the therapy. For some participants with certain conditions, additional measures like medication use and functional assessments will be monitored for shorter periods. Throughout the study, participants will undergo regular health evaluations, lab tests, and questionnaires to assess the long-term effects of KYV-101. Researchers will collect data on safety events and laboratory markers up to 15 years, with some specific tests monitored up to 5 years. The overall goal is to better understand the long-term impact and safety profile of the gene-modified therapy in people treated previously.
CONDITIONS
Brief Title
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent for the long-term follow-up study
- Received at least one infusion of KYV-101 in a previous treatment protocol
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 years
Participants previously treated with KYV-101 are followed to monitor safety and health outcomes.
Periodic visits depending on individual assessment schedule
Trial Site Locations
Total: 1 location
1
University of Colorado, Denver
Denver, Colorado, United States, 80045
Actively Recruiting
Research Team
K
Kyverna Therapeutics
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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