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

Trial ID or NCT#

NCT04911478

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Long-term Follow-up Protocol for Subjects Treated With Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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:
  1. * There are no specific exclusion criteria for this study
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

David Miklos, MD
650-723-0822

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