Long-Term Follow-Up for KYV-101 Treatment
This study is a long-term follow-up for people who have previously received KYV-101, an autologous (using your own cells) anti-CD19 CAR T-cell product. KYV-101 is a type of gene-modified therapy. The study aims to understand any delayed side effects and how long KYV-101 stays in your body. You can join if you are 18 or older and have already received at least one dose of KYV-101 in a previous study. The study will track the number of participants who experience new side effects, new cancers, or new or worsening nerve problems over 15 years. The current status of this study is unclear.
- Study design
- This is an observational study with a planned enrollment of 70 participants. It is a long-term follow-up study.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 15 years from when they entered the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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