Sengupta, Vikram
Qian, Sascha
Ransom, John T.
Suzuki, Sam
Park, David J.
Melson, Timothy I.
Williams, Brian P.
Walsh, James J.
Awili, Mustafa
Mann, Jack M.
Moseley, Timothy A. https://orcid.org/0000-0003-1352-6610
Article History
Received: 16 February 2026
Accepted: 20 April 2026
First Online: 11 May 2026
Declarations
:
: The trial protocol was approved by the institutional review board (IRB) at each site (or a centralized IRB as applicable) and overseen by a data and safety monitoring board (DSMB) that was fully independent of both study sponsor and director.
: Written informed consent (or consent by other IRB-approved process) was obtained from each patient, or patient’s legally authorized representative if the patient was unable to provide consent, following a discussion of informed consent principles with the investigator.
: Consent for publication is contained within the informed consent form and permission is granted upon signing the consent form.
: Vikram Sengupta: prior CMO at Direct Biologics, Sascha Qian: prior Associate CMO at Direct Biologics, John T. Ransom: Sr. Medical Writer at Direct Biologics, Timothy A. Moseley: CSO at Direct Biologics.