A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101 (KYSA-4)

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Dermatomyositis; Rheumatoid Arthritis (RA); Stiff Person Syndrome; Myasthaenia Gravis; Systemic Sclerosis (SSc); Refractory Lupus Nephritis
• Intervention / Treatment: Drug: KYV-101

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Kyverna Therapeutics; Phone Number: 510-925-2484; Email: clinicaltrials@kyvernatx.com

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • Recruiting
      • University of Colorado, Denver
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1	Drug: KYV-101; Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For stiff-person syndrome participants, change in time required (in seconds) from baseline to complete the Timed 25-foot Walk (T25-FW) test as assessed by the investigator through Year 4 of long-term follow-up (LTFU). The T25-FW test is a quantitative mobility and leg function performance test based on a timed 25-foot walk, with shorter times indicating better mobility and improved disease severity.	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.	For myasthenia gravis participants, change in score from baseline on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The MG-ADL questionnaire is a quantitative functional status instrument, with scores ranging from 0 to 24, with a higher score indicating worse disease severity.	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.	For myasthenia gravis participants, change in score from baseline on the Quantitative Myasthenia Gravis (QMG) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The QMG questionnaire is a quantitative muscle strength and endurance/fatigability instrument, with scores ranging from 0 to 39, with a higher score indicating worse disease severity.	Up to 5 years from study entry

Collaborators and Investigators

• Sponsor: Kyverna Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): January 1, 2041
• Study Completion (Estimated): January 1, 2041

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Skin Diseases; Spinal Cord Diseases; Myositis; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Polymyositis; Skin and Connective Tissue Diseases; Multiple Sclerosis; Lupus Nephritis; Scleroderma, Systemic; Arthritis, Rheumatoid; Dermatomyositis; Stiff-Person Syndrome
• Other Study ID Numbers: KYV101-004; 2024-511198-31-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No