The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies. Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
Study Type
OBSERVATIONAL
Enrollment
40
No intervention is administered on this study. Subjects who have received CLBR001 autologous CAR-T cells in a primary Calibr treatment trial will be followed long term in line with FDA guidance.
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Virtual Research Group- Premier Research
Morrisville, North Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Number of subjects with adverse events as assessed by CTCAE v5.0.
To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.
Time frame: To 15 years post-CLBR001 administration.
Number of subjects with replication competent lentivirus (RCL).
To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.
Time frame: To 15 years post-CLBR001 administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.