Calibr, a division of Scripps Research
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.
Inclusion Criteria: * Subjects who received at least one CLBR001 cell dose. Exclusion Criteria: * None
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.
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