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Clinical Trials in the USA / NCT07403188
Recruiting Observational

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

NCT07403188 · tracked via the Priya Life Science USA tracker
Sponsor
Kyverna Therapeutics
Phase
Observational
Started
2025-11-24
Last updated
2026-02-11

Condition(s) studied

Refractory Lupus NephritisMyasthaenia GravisStiff Person SyndromeRheumatoid Arthritis (RA)Multiple SclerosisDermatomyositisSystemic Sclerosis (SSc)

Investigational drug(s) / intervention(s)

KYV-101 →

KYV-101: Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU). — 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). — 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). — 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). — 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). — 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). — 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). — 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). — 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). — Up to 5 years from study entry

Trial sites (1)

FacilityCityRegionStatus
University of Colorado, Denver Denver Colorado Recruiting

More Kyverna Therapeutics trials in the USA

KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis Active, not recruiting
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis Recruiting

Other trials for the same condition

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Enrolling by invitation
A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS) Active, not recruiting
A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition Active, not recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) Active, not recruiting
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403188 on ClinicalTrials.gov ↗ ← All trials in the USA