ClinicalTrials.gov record NCT07403188
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective, observational long-term follow-up study of people who previously received at least one infusion of KYV-101. It aims to collect delayed adverse events and measure how long KYV-101 (an autologous CD19 CAR T-cell product) persists. Follow-up measurements include safety events and laboratory tests over multiple years (some outcomes tracked up to 15 years).
What it is studying. The study is testing long-term safety and the persistence of KYV-101 cells after prior treatment, and it tracks new or worsening health problems and specific lab markers.
What the researchers hope to learn. To collect and report delayed or long-term adverse events after KYV-101 treatment. To understand how long KYV-101 cells persist in the body. To monitor for new malignancies, neurologic or autoimmune flare-ups, hematologic disorders, and infections after treatment. To record laboratory markers related to replication-competent lentivirus, CAR detection, and anti-drug antibodies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- KYV-101
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an observational long-term follow-up: participants will have periodic health assessments and safety monitoring to collect delayed adverse events and to check persistence of KYV-101. Scheduled laboratory testing includes assays for CAR presence, replication-competent lentivirus (RCL), and anti-drug antibodies (ADA) through specified follow-up windows (some labs noted through Year 5). Follow-up for safety outcomes such as new malignancies, neurologic or autoimmune events, blood disorders, and infections may continue up to 15 years; some condition-specific measures (medication tracking for lupus nephritis; Timed 25-foot Walk for stiff-person syndrome; MG-ADL and QMG questionnaires for myasthenia gravis) are collected for shorter specified periods. The record describes assessments, lab tests, and condition-specific questionnaires/functional tests as the expected participant activities.
How the study is structured. This is a prospective observational long-term follow-up. Participants who received KYV-101 in an earlier Kyverna trial are followed over time without receiving additional study treatments. The study collects safety information, medical events (including new cancers, neurologic or autoimmune problems, hematologic disorders, and infections) and laboratory test results related to CAR T-cell persistence and immune response. Some safety endpoints are followed up to 15 years, and certain laboratory markers are assessed through Year 5.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Refractory Lupus Nephritis; Myasthaenia Gravis; Stiff Person Syndrome; Rheumatoid Arthritis (RA); Multiple Sclerosis; Dermatomyositis; Systemic Sclerosis (SSc). Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on polymyositis
This trial is also listed on this site under dermatomyositis and stiff person syndrome.
Important dates
- Study start
- Nov 24, 2025
- Primary completion
- January 2041 (estimated)
- Study completion
- January 2041 (estimated)
- Target enrollment
- 70 participants (estimated)
- Last updated on registry
- Feb 11, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Kyverna Therapeutics
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Kyverna Therapeutics 📞 510-925-2484 ✉ clinicaltrials@kyvernatx.com
Participating sites (1)
- University of Colorado, DenverRecruiting
Denver, Colorado, 80045 · United States
- Study Coordinator
Terms used on this page · explanations by MedicalUpdates.ai
- long-term follow-up
- Observation that continues for years after the study treatment, often required for gene and cell therapies.
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- CAR T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- clinical trial
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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