Recruiting

KYV-101

Sponsor:

Kyverna Therapeutics

Code:

NCT07403188

Conditions

Refractory Lupus Nephritis

Myasthaenia Gravis

Stiff Person Syndrome

Rheumatoid Arthritis (RA)

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KYV-101

Study Details

Brief summary:

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).

Conditions

Refractory Lupus Nephritis

Myasthaenia Gravis

Stiff Person Syndrome

Rheumatoid Arthritis (RA)

Multiple Sclerosis

Study ID

NCT07403188

Start date

Nov 24, 2025

Status verified date

Feb, 2026

Completion date

Jan, 2041

Anticipated

Primary completion date

Jan, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Interventions

KYV-101

Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kyverna Therapeutics

510-925-2484clinicaltrials@kyvernatx.com

Locations

University of Colorado, Denver

Recruiting

Denver, Colorado, United States, 80045

More Information

Sponsor

Kyverna Therapeutics

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kyverna Therapeutics on 2026-02-11.