Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received an Adicet Bio allogeneic γδ CAR T cell product that has been genetically engineered to express the anti-CD20 CAR by transduction with a self-inactivating, replication incompetent gamma retroviral vector. The period of follow-up is 15 years after the administration of the γδ CAR T cell product.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to a genetically engineered CAR in Adicet Bio clinical studies. Upon early termination/discontinuation or completion of the parent interventional study, subjects will enroll into this study. Collection of these data will further define the risk-benefit and efficacy profile Adicet allogeneic γδ CAR T cell investigational products.

This is an observational study, and the elements of the study design are per published guidelines for gene therapy medicinal products that utilize integrating viral vectors such as gamma retrovirus and it is important to evaluate any delayed adverse events after infusion with such products.

Inclusion criteria

• All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early
• All patients who are willing and able to adhere to the study visit schedule and other protocol requirements.
• Capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and protocol

Exclusion criteria

• There are no specific exclusion criteria for this study