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

NCT07403188 | Recruiting FDA Drug

• 2 other identifiers: KYV101-0042024-511198-31-00
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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; Dermatomyositis; Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (9)

• 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

Secondary Outcomes (4)

• For lupus nephritis participants, number of participants administered glucocorticoids and other immunosuppressants through Year 2 after KYV101 infusion.

  Up to 2 years from first KYV-101 infusion

• For stiff-person syndrome participants, change in time required (in seconds) to complete the Timed 25-foot Walk (T25-FW) through Year 4 of LTFU.

  Up to 4 years from study entry

• For myasthenia gravis participants, change in score on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire through Year 5 of LTFU.

  Up to 5 years from study entry

• For myasthenia gravis participants, change in score on the Quantitative Myasthenia Gravis (QMG) questionnaire through Year 5 of LTFU.

  Up to 5 years from study entry

Study Arms (1)

Cohort 1

Drug: KYV-101

Interventions

KYV-101 DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who received at least 1 infusion of KYV-101 in a previous KYV-101 treatment clinical study

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Kyverna Therapeutics: lead

Study Sites (1)

University of Colorado, Denver

Denver, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis; Stiff-Person Syndrome; Arthritis, Rheumatoid; Multiple Sclerosis; Dermatomyositis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Neuromuscular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Polymyositis; Myositis; Muscular Diseases; Skin Diseases

Central Study Contacts

Kyverna Therapeutics

CONTACT

510-925-2484; clinicaltrials@kyvernatx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: February 11, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): January 1, 2041
• Study Completion (Estimated): January 1, 2041
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)