Long-term follow-up after KYV-101 (CAR T) treatment
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
This follow-up will test how long KYV-101 CAR T cells persist and record any delayed side effects in people who previously received KYV-101 for autoimmune diseases like lupus nephritis, myasthenia gravis, stiff person syndrome, rheumatoid arthritis, or multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kyverna Therapeutics Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT07403188 on ClinicalTrials.gov |
What this trial studies
This is an observational long-term follow-up open to anyone who received at least one infusion of the autologous gene-modified cell therapy KYV-101 in a prior Kyverna-sponsored or investigator-initiated protocol. Participants will have periodic safety checks and laboratory testing to capture delayed adverse events and to measure persistence of the KYV-101 product in blood or other samples. The protocol is non-interventional and focuses on monitoring rather than providing new therapy. Collected data will inform the long-term safety profile and durability of the engineered CAR T cells across multiple autoimmune indications.
Who should consider this trial
Good fit: Ideal candidates are people who previously received at least one infusion of KYV-101 in a prior Kyverna-sponsored or investigator-initiated trial and can provide informed consent for follow-up visits and testing.
Not a fit: People who have never received KYV-101 or who need active therapeutic intervention rather than monitoring are unlikely to receive direct clinical benefit from this follow-up.
Why it matters
Potential benefit: If successful, the study could clarify long-term safety and how long KYV-101 cells remain detectable, helping guide future monitoring and care for treated patients.
How similar studies have performed: Long-term follow-ups of CAR T therapies in oncology have shown durable cell persistence and occasional delayed toxicities, but long-term data for CAR T approaches in autoimmune diseases like KYV-101 remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- University of Colorado, Denver — Denver, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Kyverna Therapeutics
- Email: clinicaltrials@kyvernatx.com
- Phone: 510-925-2484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.