← Back to searchRecruitingRecruiting
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
NCT07403188 · Kyverna Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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).
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
Study design
Enrollment target: 70 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-11-24
Estimated completion: 2041-01
Last updated: 2026-02-11
Interventions
Drug: KYV-101
Primary outcomes
- • 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)
Sponsor
Kyverna Therapeutics · industry
Contacts & investigators
ContactKyverna Therapeutics · contact · clinicaltrials@kyvernatx.com · 510-925-2484
All locations (1)
University of Colorado, DenverRecruiting
Denver, Colorado, United States