Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
brief summary
This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.
detailed description
As recommended by Health Authorities guidelines for human gene therapy products containing an integrated transgene, during the LTFU for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, AEs, survival information, etc. AEs recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. Samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use.
All participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.