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

Adicet Bio

Status: Invitation-only

Conditions: Lymphoma, Mantle-Cell; Lymphoma, Follicular; Marginal Zone Lymphoma; Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma; Primary Mediastinal B-cell Lymphoma

Treatments: Genetic: ADI-001

Study type: Observational

Funder types: Industry

Identifiers

NCT04911478

ADI-20200102

Details and patient eligibility

About

The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies.

Description:

This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in Adicet Bio allogeneic γδ CAR T cell study. Patients will be followed for up to 15 years post treatment of Adicet Bio allogeneic γδ CAR T cell investigational products.

Treatment:

Genetic: ADI-001