Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells

Launched by AUTOLUS LIMITED · Aug 9, 2018

Keywords

ClinConnect Summary

The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
• • 2. Patients must have provided informed consent for long-term follow-up study prior to participation.
• • 3. Patients must be able to comply with the study requirements.
• Exclusion Criteria:
• • 1. There are no specific exclusion criteria for this study.