A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
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:
Exclusion Criteria: