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Article History

Received: 30 September 2022

Revised: 30 March 2023

Accepted: 13 April 2023

First Online: 12 May 2023

Competing interests

: Dr. AMT has received clinical trial research funding (through her institution) from OBI Pharma USA Inc., IMMATICS, Parker Institute for Cancer Immunotherapy, Agenus, Tempus, Tvardi, Boston Biomedical, and Karus Therapeutics. Dr. AMT has served in a consulting or advisory role for Vincerx, Diaccurate, and BrYet. Dr. CFV has no conflicts of interest to report. Dr. RW has no conflicts of interest to report. Dr. C-SS is an employee of OBI Pharma Inc. Dr. PH was an employee of OBI Pharma Inc. at the time the study was conducted. Dr. TEP was an employee of OBI Pharma USA Inc. at the time the study was conducted.

: All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The study was approved by the institutional review board of both institutions and conducted in accordance with the ethical principles of the International Council for Harmonization Guideline for Good Clinical Practice, the Declaration of Helsinki, and applicable local regulations. The study was registered at (NCT03592264; July 19, 2018).

: Not applicable.