Long-term Follow-up Study of Allogeneic Gamma Delta (?d) CAR T Cells
Lymphoma
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
ADI-20200102 (primary)
NCI-2021-08684
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.
Eligibility
- 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
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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