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

Active:	Yes
Cancer Type:	Lymphoma Non-Hodgkin Lymphoma	NCT ID:	NCT04911478
Trial Phases:		Protocol IDs:	ADI-20200102 (primary) NCI-2021-08684
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Adicet Bio, Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT04911478

Summary

The purpose of this study is to assess long-term side effects from subjects who receive
an Adicet Bio ?d 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 ?d 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.

Objectives

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who
received an Adicet Bio allogeneic ?d 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 ?d 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 ?d 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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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