Ethics Statement
This study was conducted according to the principles of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects or Research and the Declaration of Helsinki. All patients completed documented informed consent to participate. This study was approved by the City of Hope Institutional Review Board (IRB) (no. 19184), the Northwell Health IRB (no. 20-0859), and the Mayo Clinic IRB (no. 20-010121) and is being conducted under an open US multicenter phase I trial (NCT04329494). Specifically, the present study reports results from arm 2. Results from other arms will be reported as they mature.