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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Kyverna Therapeutics
Study ID
NCT07403188
Status
Recruiting
Apply to this trial

Conditions

  • Dermatomyositis
  • Multiple Sclerosis
  • Myasthaenia Gravis
  • Refractory Lupus Nephritis
  • Rheumatoid Arthritis (RA)
  • Stiff Person Syndrome
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 24, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2041
Completion
Jan 31, 2041

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Cohort 1

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, DenverDenverColorado80045
Study Coordinator

Find similar trials in Denver, CO

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By specialty
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By research site
University of Colorado, Denver· Denver, CO

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