Clinical trial Recruiting at 1 site Observational Ages 18 and up

Long-term follow-up after KYV-101 (CAR T) treatment

Official title: A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101

Run by Kyverna Therapeutics · NCT07403188 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorKyverna Therapeutics
Industry-sponsored
Drugs / interventionsCAR T
Locations1 site (Denver, Colorado)
StatusRecruiting
StartedNovember 24, 2025
Main results expectedJanuary 2041
Study endsJanuary 2041
Registry record updatedFebruary 11, 2026
Trial IDNCT07403188 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Colorado, Denver
    Denver, Colorado, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.