RecruitingNot Applicable

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

United States70 participantsStarted 2025-11-24

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: Up to 15 years from study entry

Trial details

NCT IDNCT07403188

SponsorKyverna Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2041-01

Contact for this trial

Kyverna Therapeutics

510-925-2484 clinicaltrials@kyvernatx.com

View on ClinicalTrials.gov More Refractory Lupus Nephritis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: Up to 15 years from study entry