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

Launched by AUTOLUS LIMITED · Aug 9, 2018

Keywords

ClinConnect Summary

This long-term follow-up study tracks people who have already received AUTO CAR T cell therapy for certain blood cancers, including multiple myeloma, DLBCL, ALL (adult and pediatric), and some T-cell lymphomas. The researchers want to monitor safety and how well the therapy works for up to 15 years after the first infusion. They will look for serious side effects, any new cancers or other safety concerns, overall survival, how long the treatment effect lasts, and whether the CAR T cells stay in the body. No new treatment is given in this study—it’s all about watching and learning from people who already received AUTO CAR T therapy.

Who can join? If you are 1 year old or older, any sex, and you have already received AUTO CAR T cell therapy in a prior study, you may be invited to participate after giving informed consent for long-term follow-up and agreeing to follow the study rules. There are no specific exclusion criteria listed. The study involves visits at several sites in the United States and United Kingdom, with periodic tests such as blood samples to check for the CAR therapy’s genetic presence, monitoring for replication-competent viruses, and, if a new cancer occurs, tests to understand possible causes. Up to about 500 people may enroll, and the study does not share individual patient data publicly.

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.