NCT07403188 · Kyverna Therapeutics
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
(KYSA-4)
What this study is about
The purpose of this long-term follow-up (LTFU) study is to collect delayed side effects (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).
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Denver, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations