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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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